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

NCT04022109 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2021-07-26

No results posted yet for this study

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.

Conditions

  • Gastric Cancer
  • Atrophic Gastritis
  • Gastric Dysplasia
  • H.Pylori Infection

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

Sponsors & Collaborators

  • Technion, Israel Institute of Technology

    collaborator OTHER
  • University of Ulm

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • JLM Innovation GmbH

    collaborator UNKNOWN
  • Universitaet Innsbruck

    collaborator OTHER
  • Hospital Universitario San Ignacio

    collaborator OTHER
  • Universidad de Pamplona

    collaborator OTHER
  • Pontificia Universidad Catolica de Chile

    collaborator OTHER
  • AC Camargo Cancer Center

    collaborator OTHER
  • National Cancer Institute of Ukraine

    collaborator OTHER
  • VTT Technical Research Centre of Finland

    collaborator OTHER
  • University of Latvia

    lead OTHER

Principal Investigators

  • Hossam Haick, PhD · TECHNION, Israel Institute for Technology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-12-31
Completion
2026-12-31

Countries

  • Brazil
  • Chile
  • Colombia
  • Latvia
  • Ukraine

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04022109 on ClinicalTrials.gov