NCT07233447

Brief Summary

The incidence and mortality of stomach cancer are higher in the French West Indies than in mainland France. The prevalence of H. pylori infection associated with this cancer remains unknown in these populations. The main objective of the study is to estimate the prevalence of H. Pylori detected by immunohistochemistry in patients newly diagnosed with cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Feb 2025

Geographic Reach
1 country

2 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 Progress60%
Feb 2025Feb 2027

Study Start

First participant enrolled

February 24, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

H. PyloriGuadeloupestomach cancer

Outcome Measures

Primary Outcomes (1)

  • detection of H. Pylori in immunohistochemistry

    Detection of Helicobacter pylori will be performed by immunohistochemistry (IHC) on gastric biopsy samples collected at inclusion. The procedure aims to identify the presence of H. pylori antigens within the gastric mucosa using specific antibodies. The test will be conducted in a certified pathology laboratory according to standard diagnostic protocols. Results will be reported as positive or negative for H. pylori infection.

    Baseline

Secondary Outcomes (1)

  • positivity of anti H. Hylori serology by Elisa test

    Baseline

Eligibility Criteria

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

Patients living in Guadeloupe for more than 6 months, referred to the gastroenterology departments of the University Hospital of Guadeloupe (CHUG) and to the gastroenterology practice of Dr. Durand, with an endoscopic diagnosis of gastric cancer confirmed by histopathological examination in one of the three endoscopy centers (CHUG, Polyclinique de la Guadeloupe, and Clinique des Eaux Claires), will be invited to participate in the study following their disclosure consultation.

You may qualify if:

  • Patient over 18 years of age residing in Guadeloupe for more than 6 months and 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 scheme
  • Patient under legal protection (judicial safeguard, guardianship, curatorship, etc.)
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cabinet Galeries de Houelbourg

Baie-Mahault, 97122, Guadeloupe

RECRUITING

CHU de la Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The biological samples (serum, DNA, tumor) will be processed and stored for future research. The collection will be used for future somatic genetic analyses aimed at identifying additional disease-related risk factors. No analyses of constitutional (germline) genetic characteristics will be performed.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jacqueline Deloumeaux, MD PhD

    CHU de la Guadeloupe

    STUDY DIRECTOR
  • Moana GELU-SIMEON, MD PhD

    CHU de la Guadeloupe

    STUDY CHAIR

Central Study Contacts

Mélanie petapermal, Master degree

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

February 24, 2025

Primary Completion (Estimated)

February 24, 2027

Study Completion (Estimated)

February 24, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations