Clinical trial NCT04949737: Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies
Official title: Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies: Helico-MQ Interventional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stomach Neoplasms
Gastric Neoplasms
Helicobacter Pylori
Keywords: Helicobacter Pylori
Gastric cancer
Prevalence
French West-Indies
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Estimation of the prevalence of Helicobacter pylori
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU Martinique
Study officials:
affiliation: CHU Martinique
name: Clarisse JOACHIM-CONTARET
role: PRINCIPAL_INVESTIGATOR
References: