Prevalence of H. Pylori in Stomach Cancers in the West Indies (PyloCaGe)

November 14, 2025 updated by: Centre Hospitalier Universitaire de la Guadeloupe
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Stomach cancer is the 4th most common cancer site in the world and the 3rd cause of mortality. It is associated with infection by the Helicobacter Pylori bacterium, which colonizes the gastric mucosa in 80% of cases. The decrease of the prevalence of H. pylori infection in developed countries with the advent of antibiotic treatments is responsible for the decrease in the incidence of stomach cancer. But in the French West Indies, stomach cancer remains in excess incidence and mortality compared to France. The prevalence of H. pylori infection remains unknown, both in general population and in patients with stomach cancer. Eating habits combining high consumption of salt, meat and smoked fish could partly explain these high incidences. Furthermore, recent observations suggest that environmental risk factors (pesticides pollution) could also be involved in the occurrence of this cancer. Estimating the prevalence of H. pylori in stomach cancers will improve the epidemiological knowledge of this cancer with high incidence rates and prevention measures.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Subject participating in another research study that includes an exclusion period still ongoing at the time of pre-inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of H. Pylori in immunohistochemistry
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
positivity of anti H. Hylori serology by Elisa test
Time Frame: Baseline
Positivity of anti-Helicobacter pylori serology determined by ELISA test performed on serum samples collected at inclusion. Results will be reported as positive or negative for H. pylori antibodies.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Investigators

  • Study Director: Jacqueline Deloumeaux, MD PhD, CHU de la Guadeloupe
  • Study Chair: Moana Gelu-Simeon, MD PhD, CHU de la Guadeloupe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

February 24, 2027

Study Completion (Estimated)

February 24, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAP_RIPH2_2020/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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