RecruitingNCT04022109

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


Sponsor

University of Latvia

Enrollment

5,000 participants

Start Date

Nov 1, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Patients with verified gastric cancer (Group 1 \& 2)
  • Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 \& 5)
  • Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 4)
  • Motivation to participate in the study
  • Physical status allowing volatile marker sampling and other procedures within the protocol
  • Signed consent

Exclusion Criteria3

  • Known other active cancer
  • Ventilation problems, airway obstruction
  • Unwillingness or inability to co-operate

Interventions

DEVICEBreath 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

PROCEDURESurgery material collection for VOC headspace analysis

Only for gastric cancer patients undergoing surgery (Group 1)

DIAGNOSTIC_TESTUpper 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_TESTMicrobiota 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

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NCT04022109


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