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

Stomach Neoplasms Clinical Trial

— Hélico-MQ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04949737
• Other study ID #: 20_RIPH2_22
• Secondary ID: 2020-A02412-37
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: Clarisse JOACHIM-CONTARET
• Phone: +596596559674
• Email: clarisse.joachim[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Gastric Neoplasms
• Helicobacter Pylori
• Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Martinique	CHU Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the prevalence of Helicobacter pylori	Helicobacter Pylori has detected by immunohistochemistry in the stomach of patients with gastric cancer.	At baseline