Menu
Recruiting NCT04949737

Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies

Observational Stomach Neoplasms Gastric Neoplasms Helicobacter Pylori

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Helicobacter Pylori detection.
Who it may be relevant to
Registry conditions: Stomach Neoplasms, Gastric Neoplasms, Helicobacter Pylori. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Martinique
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies: Helico-MQ Interventional Study

Overview

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.

Detailed description

In the Antilles-Guyana, gastric cancer affects approximately 80 men and women each year in Guadeloupe and Martinique, and 20 in French Guiana. It is more frequent than in France and represents 4.5% of cancers in men in Martinique, 5.3% in Guadeloupe and 5.7% in French Guyana. It is the 3rd most common cancer site in men in Guadeloupe and Martinique, and the 4th in French Guiana. In women, it is the 3rd most frequent cancer in Martinique and the 4th in Guadeloupe, whereas it is less frequent in French Guiana.

Studies are needed to estimate this prevalence in the general population and in cancer patients. The prevalence of Helicobacter pylori infection is not well known in the general population in the Caribbean and when gastric cancer is diagnosed, the bacterium is rarely tested.

Dietary habits in our regions are characterized by a high consumption of salt (salted), meat and smoked fish. These dietary habits, common to some Southeast Asian countries, could partly explain the high incidence of stomach cancer observed. But environmental risk factors could also be involved.

Patients referred to gastroenterology with a suspected endoscopic diagnosis of gastric cancer will be offered to participate in the study after the fibroscopy has been performed and their consent will be obtained for the use of diagnostic specimen remains for research purposes.

Interventions

  • Biological Helicobacter Pylori detection
    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.

Primary outcome measures

  • Estimation of the prevalence of Helicobacter pylori [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Martinique · 1 center
  • CHU Martinique — Fort-de-France

Identifiers

NCT: NCT04949737 · 20_RIPH2_22 · 2020-A02412-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗