NCT04022109

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
5 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2019Dec 2026

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 26, 2021

Status Verified

November 1, 2020

Enrollment Period

3.1 years

First QC Date

July 12, 2019

Last Update Submit

July 19, 2021

Conditions

Gastric CancerAtrophic GastritisGastric DysplasiaH.Pylori Infection

Keywords

Volatile organic compoundsBreath testingGastric cancerAtrophic gastritisPrecancerous lesionsScreeningNanosensor technologyGC-MS

Outcome Measures

Primary Outcomes (2)

  • Characteristic VOC pattern identification for gastric cancer detection

    The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected

    2 years following initiation of patient recruitment

  • Specific chemistry identification in the exhaled breath

    Identification of specific chemistries (GC-MS analysis) originating from gastric cancer

    2 years following initiation of patient recruitment

Secondary Outcomes (3)

  • Characteristic VOC pattern identification for gastric precancerous lesion detection

    2.5 years following initiation of patient recruitment

  • Identification of the best-performing sensors

    3 years following initiation of patient recruitment

  • Gut microbiota analysis in relation to breath VOCs

    3 years following initiation of patient recruitment

Other Outcomes (1)

  • Confounding factor analysis

    3 years following initiation of patient recruitment

Study Arms (5)

Gastric cancer patients undergoing surgery

Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management

Device: Breath sampling for VOC detectionProcedure: Surgery material collection for VOC headspace analysisDiagnostic Test: Upper endoscopyDiagnostic Test: Microbiota testing

Gastric cancer patients

Patients with histologically confirmed gastric cancer (adenocarcinoma)

Device: Breath sampling for VOC detectionDiagnostic Test: Upper endoscopyDiagnostic Test: Microbiota testing

Control group patients without gastric cancer

Patients without gastric malignant disease according to data obtained in upper endoscopy

Device: Breath sampling for VOC detectionDiagnostic Test: Upper endoscopyDiagnostic Test: Microbiota testing

Average risk population

Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer

Device: Breath sampling for VOC detectionDiagnostic Test: Upper endoscopyDiagnostic Test: Microbiota testing

Patients with dyspeptic symptoms

Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)

Device: Breath sampling for VOC detectionDiagnostic Test: Upper endoscopyDiagnostic Test: Microbiota testing

Interventions

Breath sampling for VOC detectionDEVICE

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

Also known as: Serum, plasma sampling for group description and stratification
Average risk populationControl group patients without gastric cancerGastric cancer patientsGastric cancer patients undergoing surgeryPatients with dyspeptic symptoms
Surgery material collection for VOC headspace analysisPROCEDURE

Only for gastric cancer patients undergoing surgery (Group 1)

Gastric cancer patients undergoing surgery
Upper endoscopyDIAGNOSTIC_TEST

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)

Also known as: Histological and microbial evaluation of biopsy samples and gastric content
Average risk populationControl group patients without gastric cancerGastric cancer patientsGastric cancer patients undergoing surgeryPatients with dyspeptic symptoms
Microbiota testingDIAGNOSTIC_TEST

Faecal and gastric contents and biopsy samples for microbiota testing

Average risk populationControl group patients without gastric cancerGastric cancer patientsGastric cancer patients undergoing surgeryPatients with dyspeptic symptoms

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patient population will be recruited in the major specialized cancer centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil) Control group patients will be recruited in the major specialized endoscopy centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil), most frequently - the same institutions as for cancer patient recruitment General population group (40-64 years) will be predominantly recruited in Latvia from the general population Symptomatic patient validation cohort (Group 5) will be predominantly recruited in Chile from the endoscopy referrals

You may qualify if:

  • Patients with verified gastric cancer (Group 1 \& 2)
  • Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 \& 5)
  • Motivation to participate in the study
  • Physical status allowing volatile marker sampling and other procedures within the protocol
  • Signed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

A.C.Camargo Cancer Center

São Paulo, Brazil

RECRUITING

Pontificia Universidad Catolica de Chile

Santiago, Chile

NOT YET RECRUITING

Centro Javeriano de Oncología, San Ignacio University Hospital

Bogotá, Colombia

NOT YET RECRUITING

Institute of Clinical and Preventive Medicine, University of Latvia

Riga, LV1050, Latvia

RECRUITING

National Cancer Institute of Ukraine

Kiev, Ukraine

RECRUITING

Related Publications (6)

  • Mochalski P, Leja M, Gasenko E, Skapars R, Santare D, Sivins A, Aronsson DE, Ager C, Jaeschke C, Shani G, Mitrovics J, Mayhew CA, Haick H. Ex vivo emission of volatile organic compounds from gastric cancer and non-cancerous tissue. J Breath Res. 2018 Jul 30;12(4):046005. doi: 10.1088/1752-7163/aacbfb.

    PMID: 29893713BACKGROUND

  • Krilaviciute A, Stock C, Leja M, Brenner H. Potential of non-invasive breath tests for preselecting individuals for invasive gastric cancer screening endoscopy. J Breath Res. 2018 Apr 4;12(3):036009. doi: 10.1088/1752-7163/aab5be.

    PMID: 29528036BACKGROUND

  • Amal H, Leja M, Funka K, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Haick H. Detection of precancerous gastric lesions and gastric cancer through exhaled breath. Gut. 2016 Mar;65(3):400-7. doi: 10.1136/gutjnl-2014-308536. Epub 2015 Apr 13.

    PMID: 25869737BACKGROUND

  • Krilaviciute A, Heiss JA, Leja M, Kupcinskas J, Haick H, Brenner H. Detection of cancer through exhaled breath: a systematic review. Oncotarget. 2015 Nov 17;6(36):38643-57. doi: 10.18632/oncotarget.5938.

    PMID: 26440312BACKGROUND

  • Leja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28.

    PMID: 25439074BACKGROUND

  • Leja M, Amal H, Lasina I, Skapars R, Sivins A, Ancans G, Tolmanis I, Vanags A, Kupcinskas J, Ramonaite R, Khatib S, Bdarneh S, Natour R, Ashkar A, Haick H. Analysis of the effects of microbiome-related confounding factors on the reproducibility of the volatolomic test. J Breath Res. 2016 Jun 24;10(3):037101. doi: 10.1088/1752-7155/10/3/037101.

    PMID: 27341527BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled air samples being stored in specific adsorbent media Plasma/serum samples for group stratification Biopsy samples from stomach for histological assessment and microbiota analysis Gastric content samples for GC-MS and microbiota analysis Faecal samples for occult blood testing and microbiota analysis

MeSH Terms

Conditions

Stomach NeoplasmsGastritis, Atrophic

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGastritisGastroenteritis

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Hossam Haick, PhD

    TECHNION, Israel Institute for Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcis Leja, MD, PhD

CONTACT

+37129497500marcis.leja@lu.lv

Daiga Santare, MD, PhD

CONTACT

+37129221107daiga.santare@lu.lv

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute of Clinical and Preventive Medicine

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

November 1, 2019

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

July 26, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)UA(1)CO(1)CL(1)LA(1)