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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de la Guadeloupe

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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