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RECRUITING
NCT04022109

Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

Sponsor: University of Latvia

View on ClinicalTrials.gov

Summary

The study is aimed to determine the potential of volatile marker testing for gastric cancer screening. 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2019-11-01

Completion Date

2026-12

Last Updated

2021-07-26

Healthy Volunteers

Not specified

Interventions

DEVICE

Breath sampling for VOC detection

Breath sampling will be performed by using a special sensor device and or GC-MS analysis (by collecting breath samples in adsorbent tubes). Pepsinogen testing will be used in a subgroup to identify serological increased risk for atrophy

PROCEDURE

Surgery material collection for VOC headspace analysis

Only for gastric cancer patients undergoing surgery (Group 1)

DIAGNOSTIC_TEST

Upper endoscopy

Routine endoscopic evaluation with a standard biopsy work-up according to updated Sydney system. Additional gastric contents for GC-MS and microbiota analysis in a subgroup. Endoscopy will be used only according to the clinical indications (in Group 4 - according to the results of pepsinogen tests)

DIAGNOSTIC_TEST

Microbiota testing

Faecal and gastric contents and biopsy samples for microbiota testing

Locations (5)

A.C.Camargo Cancer Center

São Paulo, Brazil

Pontificia Universidad Catolica de Chile

Santiago, Chile

Centro Javeriano de Oncología, San Ignacio University Hospital

Bogotá, Colombia

Institute of Clinical and Preventive Medicine, University of Latvia

Riga, Latvia

National Cancer Institute of Ukraine

Kiev, Ukraine