Volatiles in Breath and Headspace Analysis - Diagnostic Markers

NCT03228095 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2018-08-21

No results posted yet for this study

Summary

Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis (skin, surgery material, other tissue) and exhaled breath is feasible using affordable user-friendly novel nano-chemo sensors that can accurately be used for screening and monitoring purpose

Conditions

Interventions

DIAGNOSTIC_TEST

VOC detection in breath and in skin headspace

VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing

DIAGNOSTIC_TEST

Breath sampling

Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)

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

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

Whole blood/ Plasma / serum sampling

Whole blood/Plasma/serum sampling will be used to obtain information for group stratification

DIAGNOSTIC_TEST

Faecal sampling

Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis

PROCEDURE

Histological examination of surgical specimen

Routine histological exam for patients undergoing curative or palliative surgery. Indication for surgery are set based on underlying condition. Study does not interfere with decision making for surgical treatment

DIAGNOSTIC_TEST

Headspace analysis for biological material

VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.

Sponsors & Collaborators

  • Technion, Israel Institute of Technology

    collaborator OTHER
  • Riga East University Hospital

    collaborator UNKNOWN
  • JLM Innovation GmbH

    collaborator UNKNOWN
  • University of Latvia

    lead OTHER

Principal Investigators

  • Mārcis Leja, PhD, MD · University of Latvia

  • Lelde Lauka, MD · University of Latvia

  • Andra Cīrule, MD · Riga East University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2019-12-20
Completion
2025-12-31

Countries

  • Latvia

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 NCT03228095 on ClinicalTrials.gov