Volatiles in Breath and Headspace Analysis - Diagnostic Markers
- Conditions
- Colorectal PolypLiver CancerFlu, HumanOther Infectious DiseasesTuberculosisGastric CancerAtrophic GastritisGastric DysplasiaPancreatitis, ChronicLiver Cirrhosis
- Interventions
- Diagnostic Test: Breath samplingDiagnostic Test: VOC detection in breath and in skin headspaceProcedure: Upper endoscopy with biopsiesProcedure: Colonoscopy with biopsiesProcedure: Whole blood/ Plasma / serum samplingDiagnostic Test: Headspace analysis for biological materialDiagnostic Test: Faecal samplingProcedure: Histological examination of surgical specimen
- Registration Number
- NCT03228095
- Lead Sponsor
- University of Latvia
- Brief Summary
Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis (skin, surgery material, other tissue) and exhaled breath is feasible using affordable user-friendly novel nano-chemo sensors that can accurately be used for screening and monitoring purpose
- Detailed Description
Study propose to explore a novel approach for the diagnosis and monitoring of diseases. The approach is based on the detection of volatile organic compounds (VOCs) that are emitted from the cells and detected directly from tissue, such as skin, surgery material, blood as well as from exhaled breath.
In the literature there are several reports on VOCs which can be detected by Gas Chromatography - Mass Spectrometry (GC-MS) means directly from: (i) the headspace of TB cells (i.e., the mixture of volatile biomarkers trapped above the TB cells in a sealed vessel); (ii) the exhaled breath or (iii) from urine. Excellent results in detection of the tuberculosis disease by using nanosensor array were shown by Nakhleh et al achieved 90% sensitivity, 93% specificity and 92% accuracy in discrimination between healthy and diseased patients using electronic nose devices with a single sensor. None of the reported studies identified the tentative recognition of the tuberculosis-related VOCs and quantified the concentration differences between samples from ill and healthy controls. Further investigation of the exhaled breath tuberculosis-related VOC by GC-MS means will improve the knowledge and simultaneously will help to improve the nanosensor array design.
Several studies have shown that disease-rated VOC patterns can be transmitted through the skin, and, therefore, skin can be used as a source for disease detection and identification. The principle of this detection approach is that disease-related changes are reflected in measurable changes in the skin through exchange via the blood. In addition, several studies have suggested that the VOC levels are elevated even in early stages of the disease, because they reflect a change in the human's body chemistry (as a result of the development of disease condition), rather than the amount of infected cells. Complementary studies have shown that VOCs can be emitted to the skin within minutes after they have emerged in the infected part of the human's body. What is particularly significant about this approach is that each type of (infectious) disease has its own unique pattern of VOCs, and, therefore, the presence of one (infectious) disease would not screen other disease types. Nevertheless, to the best of our knowledge, the detection of tuberculosis VOCs through skin has not been examined yet. Additionally, all studies targeting skin VOCs have been carried out by means of spectrometry and spectroscopy techniques. In few cases, electronic nose devices were used. These techniques are powerful tools for detecting VOCs. However, to date, the use of these techniques has been impeded by the need for moderately to highly expensive equipment's, the high levels of expertise required to operate such instruments, the speed required for sampling and analysis, and the need for preconcentration techniques. For VOC skin testing and breath testing of tuberculosis to become widely used in clinical practice, several advances in the knowledge of tuberculosis specific VOCs and sensor development need to occur. Nanoparticles containing flexible sensors, based on organic films, are more likely to become a clinical diagnostic tool, because they are significantly smaller, easier-to-use, and significantly less expensive.
In recent years comprehensive studies have shown excellent data for using VOCs from exhaled breath as tool for diagnosing gastric cancer. In one of the biggest studies carried out by Chinese and Latvian centers, malignancy could be identified with 89% sensitivity and 90% specificity after cross-validation, irrespective of important confounding factors in gastric patients such as tobacco or alcohol consumption and H. pylori infection. A breath test for GC staging could also be demonstrated by distinguishing stage I\&II cancers from stage III\&IV cancers with 89% sensitivity and 94% specificity. These studies used both - mass spectometry and nano-sensors technologies. Most recent study published in ASC Nano journal in January 2017 reported on more extended use of nanoarry sensors in breath analysis, blind experiments showed that 86% accuracy could be achieved with the artificially intelligent nanoarray, allowing both detection and discrimination between the different disease conditions examined (chronic kidney failure, idiopathic Parkinson's disease, atypical Parkinsonism , multiple sclerosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pulmonary arterial hypertension, pre-eclampsia in pregnant women, head and neck cancer, lung cancer, colorectal cancer, bladder cancer, kidney cancer, prostate cancer, gastric cancer, and ovarian cancer. Analysis of the artificially intelligent nanoarray also showed that each disease has its own unique breathprint, and that the presence of one disease would not screen out others.
Therefore, this study is aimed to test VOCs detecting technologies as diagnostic and monitoring tools for digestive tract and infectious diseases.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
- Informed Consent signed
- Individual with targeted disease/lesion (tuberculosis, gastric cancer, gastric dysplasia, high/ normal/ low risk gastric lesions, colorectal cancer, high-risk colorectal lesions, low-risk colorectal adenoma, pancreatic cancer, chronic pancreatitis, liver cancer, chronic liver disease, other infectious diseases, oncological diseases of other location)
Exclusion Criteria
- Informed Consent not signed
- Other active cancer at the time of inclusion for particular study group
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Active Tuberculosis Whole blood/ Plasma / serum sampling Participants with Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Group of Control (Tuberculosis) Whole blood/ Plasma / serum sampling Participants Without Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Gastric dysplasia Breath sampling Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Gastric dysplasia Whole blood/ Plasma / serum sampling Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Active Tuberculosis VOC detection in breath and in skin headspace Participants with Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Gastric cancer Histological examination of surgical specimen Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment Liver cancer Breath sampling Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Active Tuberculosis Headspace analysis for biological material Participants with Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Group of Control (Tuberculosis) Headspace analysis for biological material Participants Without Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Gastric cancer Breath sampling Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment Gastric cancer Upper endoscopy with biopsies Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment Gastric cancer Faecal sampling Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment Gastric dysplasia Upper endoscopy with biopsies Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Gastric cancer Whole blood/ Plasma / serum sampling Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment High-risk gastric lesions Upper endoscopy with biopsies Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material Colorectal low-risk adenoma Histological examination of surgical specimen Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Colorectal low-risk adenoma Headspace analysis for biological material Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Group of control (colorectal) Breath sampling Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Group of control (colorectal) Colonoscopy with biopsies Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Pancreatic cancer Whole blood/ Plasma / serum sampling Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Chronic pancreatitis Breath sampling Patients with clinically and/or histologically and/or radiologically confirmed chronic pancreatitis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Active Tuberculosis Breath sampling Participants with Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Group of Control (Tuberculosis) VOC detection in breath and in skin headspace Participants Without Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Group of Control (Tuberculosis) Breath sampling Participants Without Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material Gastric cancer Headspace analysis for biological material Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment Gastric dysplasia Faecal sampling Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Gastric dysplasia Histological examination of surgical specimen Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal cancer Histological examination of surgical specimen Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal cancer Headspace analysis for biological material Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal high-risk lesions Whole blood/ Plasma / serum sampling Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal high-risk lesions Faecal sampling Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Gastric dysplasia Headspace analysis for biological material Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen High-risk gastric lesions Histological examination of surgical specimen Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material High-risk gastric lesions Headspace analysis for biological material Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material Normal and low-risk gastric lesions Breath sampling Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Normal and low-risk gastric lesions Faecal sampling Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Colorectal cancer Breath sampling Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal cancer Faecal sampling Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal low-risk adenoma Breath sampling Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Colorectal low-risk adenoma Whole blood/ Plasma / serum sampling Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Group of control (colorectal) Headspace analysis for biological material Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen High-risk gastric lesions Breath sampling Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material High-risk gastric lesions Whole blood/ Plasma / serum sampling Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material Colorectal high-risk lesions Breath sampling Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen High-risk gastric lesions Faecal sampling Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material Normal and low-risk gastric lesions Whole blood/ Plasma / serum sampling Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Normal and low-risk gastric lesions Headspace analysis for biological material Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Colorectal cancer Whole blood/ Plasma / serum sampling Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal high-risk lesions Headspace analysis for biological material Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal low-risk adenoma Colonoscopy with biopsies Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Average risk general population Breath sampling Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Normal and low-risk gastric lesions Upper endoscopy with biopsies Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Colorectal cancer Colonoscopy with biopsies Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal high-risk lesions Colonoscopy with biopsies Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Colorectal low-risk adenoma Faecal sampling Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Pancreatic cancer Breath sampling Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Pancreatic cancer Histological examination of surgical specimen Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Pancreatic cancer Headspace analysis for biological material Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Liver cancer Headspace analysis for biological material Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Chronic liver disease Breath sampling Patients with histologically confirmed liver cirrhosis of viral or other ethiology Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Chronic liver disease Headspace analysis for biological material Patients with histologically confirmed liver cirrhosis of viral or other ethiology Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Colorectal high-risk lesions Histological examination of surgical specimen Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Group of control (colorectal) Whole blood/ Plasma / serum sampling Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Group of control (colorectal) Faecal sampling Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen Average risk general population Whole blood/ Plasma / serum sampling Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Liver cancer Whole blood/ Plasma / serum sampling Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Liver cancer Histological examination of surgical specimen Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Upper respiratory tract acute infections Whole blood/ Plasma / serum sampling Patients with serologically confirmed infectious disease or individuals of high risk (e.g. population in season of flu epidemy). This group does not include tuberculosis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Oncological diseases of other locations Whole blood/ Plasma / serum sampling Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Average risk general population Faecal sampling Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Average risk general population Headspace analysis for biological material Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Chronic pancreatitis Whole blood/ Plasma / serum sampling Patients with clinically and/or histologically and/or radiologically confirmed chronic pancreatitis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Chronic pancreatitis Headspace analysis for biological material Patients with clinically and/or histologically and/or radiologically confirmed chronic pancreatitis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Upper respiratory tract acute infections Headspace analysis for biological material Patients with serologically confirmed infectious disease or individuals of high risk (e.g. population in season of flu epidemy). This group does not include tuberculosis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Oncological diseases of other locations Histological examination of surgical specimen Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Chronic liver disease Whole blood/ Plasma / serum sampling Patients with histologically confirmed liver cirrhosis of viral or other ethiology Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Oncological diseases of other locations Headspace analysis for biological material Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Upper respiratory tract acute infections Breath sampling Patients with serologically confirmed infectious disease or individuals of high risk (e.g. population in season of flu epidemy). This group does not include tuberculosis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Oncological diseases of other locations Breath sampling Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
- Primary Outcome Measures
Name Time Method Performance of nanoarray sensor testing to detect target lesions and diseases At the time of breath sampling Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
Specific VOC detected 2 years Tuberculosis specific VOC detected in breath and in skin headspace
- Secondary Outcome Measures
Name Time Method VOC pattern changes following treatment At baseline, 3 and/or 6 months after treatment (other time frame according to study group) VOC pattern changes after specific required treatment (medical eradication of bacteria/viruses, surgery/endoscopic removal for cancers or high risk lesion)
Groups of gastrointestinal microbiota correlating to VOCs At the time of sampling List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs
Specific VOC patterns for target disease or lesion and risk groups At the time of breath sampling List of VOCs assayed by GC-MS with statistical difference between the study groups
VOC pattern changes in relapse of disease for early recognition and treatment At baseline, 3 and/or 6 months after treatment (other time frame according to study group) VOC pattern changes at the time of surveillance in case of relapse (malignant diseases).
Trial Locations
- Locations (1)
University of Latvia
🇱🇻Riga, Latvia