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Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of Latvia
Riga, Latvia
Lithuanian University of Health Sciences
Kaunas, Lithuania
Start Date
January 1, 2014
Primary Completion Date
June 30, 2017
Completion Date
June 30, 2017
Last Updated
August 21, 2018
2,022
ACTUAL participants
Breath sampling for volatile marker detection
PROCEDURE
Upper endoscopy with biopsies
PROCEDURE
Colonoscopy with biopsies or lesion removal when required
PROCEDURE
Plasma/serum sampling
PROCEDURE
Faecal sample acquisition
PROCEDURE
Histological evaluation of the surgery material
PROCEDURE
Lead Sponsor
University of Latvia
Collaborators
NCT06696768
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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