Volatile Markers in Digestive Cancer

Completed

• Conditions: Gastric Cancer; Peptic Ulcer Disease; Atrophic Gastritis; Intestinal Metaplasia; H.Pylori Infection; Normal Control; Average-risk General Population; Colorectal Cancer; Colorectal Adenoma
• Interventions: Procedure: Breath sampling for volatile marker detection; Procedure: Colonoscopy with biopsies or lesion removal when required; Procedure: Upper endoscopy with biopsies; Procedure: Plasma/serum sampling; Procedure: Faecal sample acquisition; Procedure: Histological evaluation of the surgery material

• Registration Number: NCT02332213
• Lead Sponsor: University of Latvia

Brief Summary

The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.

The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

Detailed Description

Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.

Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.

Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).

The study will be conducted by utilizing the experience of institutions in the European Union and Israel.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-30
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2022

Inclusion Criteria

• Patients with verifies colorectal cancer (Group 1)
• Patients with verified gastric cancer (Group 5)
• Patients undergoing colonoscopy due to clinical indications (group 2-4)
• Patients undergoing upper endoscopy due to clinical indications (Group 6-8)
• Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9)
• Motivation to participate in the study
• Physical status allowing volatile marker sampling and other procedures within the protocol
• Signed consent

Exclusion Criteria

• Known other active cancer
• Ventilation problems, airway obstruction
• Unwillingness or inability to co-operate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. Colorectal cancer	Histological evaluation of the surgery material	Patients with histologically confirmed colorectal cancer (adenocarcinoma)
2. Colorectal high-risk lesions	Colonoscopy with biopsies or lesion removal when required	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.
2. Colorectal high-risk lesions	Faecal sample acquisition	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.
3. Colorectal low-risk adenoma	Faecal sample acquisition	Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria
2. Colorectal high-risk lesions	Breath sampling for volatile marker detection	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.
3. Colorectal low-risk adenoma	Breath sampling for volatile marker detection	Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria
5. Gastric cancer	Upper endoscopy with biopsies	Patients with histologically confirmed gastric cancer (adenocarcinoma)
5. Gastric cancer	Faecal sample acquisition	Patients with histologically confirmed gastric cancer (adenocarcinoma)
7. High-risk gastric lesions	Breath sampling for volatile marker detection	Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5)
7. High-risk gastric lesions	Plasma/serum sampling	Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5)
1. Colorectal cancer	Breath sampling for volatile marker detection	Patients with histologically confirmed colorectal cancer (adenocarcinoma)
1. Colorectal cancer	Colonoscopy with biopsies or lesion removal when required	Patients with histologically confirmed colorectal cancer (adenocarcinoma)
1. Colorectal cancer	Plasma/serum sampling	Patients with histologically confirmed colorectal cancer (adenocarcinoma)
1. Colorectal cancer	Faecal sample acquisition	Patients with histologically confirmed colorectal cancer (adenocarcinoma)
3. Colorectal low-risk adenoma	Plasma/serum sampling	Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria
4. Group of control (colorectal)	Colonoscopy with biopsies or lesion removal when required	Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.
6. Gastric dysplasia	Plasma/serum sampling	Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach
8. Normal and low-risk gastric lesions	Breath sampling for volatile marker detection	Staged 0-III according to OLGIM. Dysplasia should be excluded
2. Colorectal high-risk lesions	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.
3. Colorectal low-risk adenoma	Colonoscopy with biopsies or lesion removal when required	Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria
5. Gastric cancer	Breath sampling for volatile marker detection	Patients with histologically confirmed gastric cancer (adenocarcinoma)
6. Gastric dysplasia	Breath sampling for volatile marker detection	Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach
6. Gastric dysplasia	Upper endoscopy with biopsies	Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach
6. Gastric dysplasia	Faecal sample acquisition	Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach
7. 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, but excluding those with dysplasia (Group 5)
4. Group of control (colorectal)	Breath sampling for volatile marker detection	Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.
4. Group of control (colorectal)	Faecal sample acquisition	Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.
7. High-risk gastric lesions	Faecal sample acquisition	Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5)
8. Normal and low-risk gastric lesions	Plasma/serum sampling	Staged 0-III according to OLGIM. Dysplasia should be excluded
9. Average risk population	Breath sampling for volatile marker detection	Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer.
4. Group of control (colorectal)	Plasma/serum sampling	Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.
5. Gastric cancer	Plasma/serum sampling	Patients with histologically confirmed gastric cancer (adenocarcinoma)
5. Gastric cancer	Histological evaluation of the surgery material	Patients with histologically confirmed gastric cancer (adenocarcinoma)
8. Normal and low-risk gastric lesions	Faecal sample acquisition	Staged 0-III according to OLGIM. Dysplasia should be excluded
9. Average risk population	Plasma/serum sampling	Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer.
9. Average risk population	Faecal sample acquisition	Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer.
8. Normal and low-risk gastric lesions	Upper endoscopy with biopsies	Staged 0-III according to OLGIM. Dysplasia should be excluded

Primary Outcome Measures

Name	Time	Method
Performance of nanoarray sensor testing to detect target lesions	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
VOCs differentiating the study groups	At the time of breath sampling	List of VOCs assayed by GC-MS with statistical difference between the study groups

Secondary Outcome Measures

Name	Time	Method
VOC pattern changes following treatment	At baseline and every 6 months within 3 year period	Significant change in VOC content before and following treatment (surgery, medical therapy, combined)
Identification of characteristic VOC pattern in risk age groups	At the time of sampling	List of characteristic VOCs in general population at risk for developing gastrointestinal cancer, including analysis of confounding factors, e.g. dietary habits, smoking, and profession.
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

Trial Locations

Locations (2)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania

University of Latvia; 🇱🇻 Riga, Latvia