Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Latvia
- Enrollment
- 2,022
- Locations
- 2
- Primary Endpoint
- Performance of nanoarray sensor testing to detect target lesions
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Performance of nanoarray sensor testing to detect target lesions
Time Frame: 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
Time Frame: At the time of breath sampling
List of VOCs assayed by GC-MS with statistical difference between the study groups
Secondary Outcomes
- VOC pattern changes following treatment(At baseline and every 6 months within 3 year period)
- Identification of characteristic VOC pattern in risk age groups(At the time of sampling)
- Groups of gastrointestinal microbiota correlating to VOCs(At the time of sampling)