NCT02332213

Volatile Markers in Digestive Cancer

Volatile Marker Testing for Digestive Cancer and Precancerous Lesion Detection, Evaluation of Confounding Factors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,022 (actual)
• Sponsor: University of Latvia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer
• Colorectal Adenoma
• Gastric Cancer
• Peptic Ulcer Disease
• Atrophic Gastritis
• Intestinal Metaplasia
• H.Pylori Infection
• Normal Control
• Average-risk General Population

Interventions

Type	Name	Description
PROCEDURE	Breath sampling for volatile marker detection	Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
PROCEDURE	Upper endoscopy with biopsies	Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
PROCEDURE	Colonoscopy with biopsies or lesion removal when required	Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
PROCEDURE	Plasma/serum sampling	Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
PROCEDURE	Faecal sample acquisition	Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
PROCEDURE	Histological evaluation of the surgery material	The material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention)

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2015-01-06
• Last updated: 2018-08-21

Locations

2 sites across 2 countries: Latvia, Lithuania