NCT04949737

Brief Summary

Estimating the prevalence of Helicobacter Pylori infection in newly diagnosed stomach cancers in the West-Indies will help to understand the epidemiology of this cancer, which is over-incident in the West Indies compared to France. In addition, the constitution of a biobank (tumor tissues, healthy tissues and serum) will allow to set up in a second time etiological studies to identify other risk factors in particular in connection with the exposure to environmental pollutants to adapt the prevention measures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

June 16, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
4.3 years until next milestone

Study Start

First participant enrolled

October 9, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

June 16, 2021

Last Update Submit

March 26, 2026

Conditions

Keywords

Helicobacter PyloriGastric cancerPrevalenceFrench West-Indies

Outcome Measures

Primary Outcomes (1)

  • Estimation of the prevalence of Helicobacter pylori

    Helicobacter Pylori has detected by immunohistochemistry in the stomach of patients with gastric cancer.

    At baseline

Study Arms (1)

Helicobacter Pylori detection

Systematic biopsies of the tumor and the gastric cavity will be performed during the initial fibroscopy in accordance with the recommendations of the French Society of Digestive Endoscopy (SFED).

Biological: Helicobacter Pylori detection

Interventions

Biopsies will be sent to the referral anatomopathology laboratory. The search for Helicobacter pylori will be performed by immunohistochemistry. An additional blood sample for serological testing will be taken during the initial workup. Additional data will be collected through a questionnaire.

Helicobacter Pylori detection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligible patients (with a suspected endoscopic diagnosis of gastric cancer) will be selected either at the Martinique University Hospital or at the Sainte-Marie clinic during consultations or hospitalizations.

You may qualify if:

  • Patient over 18 years of age, residing for at least 6 months in Martinique, with a primary diagnosis of gastric cancer
  • Patient having read the information note and having signed the consent to participate in the study
  • Patient with social security coverage

You may not qualify if:

  • Refusal to participate
  • Patient who could not answer the questionnaires
  • Patient not affiliated to a social security system
  • Patient not fluent in French
  • Patient under legal protection (legal protection, guardianship, curators, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Martinique

Fort-de-France, 97261, Martinique

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples retained for extraction of DNA from whole blood

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Clarisse JOACHIM-CONTARET

    CHU Martinique

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 2, 2021

Study Start

October 9, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations