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

• 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

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)

University of Latvia; 🇱🇻 Riga, Latvia

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania