Hélico-MQ: Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies

Sponsor
University Hospital Center of Martinique (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04949737
Collaborator
(none)
112
1
10
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Helicobacter Pylori detection

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
112 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies: Helico-MQ Interventional Study
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Helicobacter Pylori detection

Systematic biopsies of the tumor and the gastric cavity will be performed during the initial fibroscopy in accordance with the recommendations of the French Society of Digestive Endoscopy (SFED).

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.

Outcome Measures

Primary Outcome Measures

  1. Estimation of the prevalence of Helicobacter pylori [At baseline]

    Helicobacter Pylori has detected by immunohistochemistry in the stomach of patients with gastric cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Martinique Fort-de-France Martinique 97261

Sponsors and Collaborators

  • University Hospital Center of Martinique

Investigators

  • Principal Investigator: Clarisse JOACHIM-CONTARET, CHU Martinique

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Center of Martinique
ClinicalTrials.gov Identifier:
NCT04949737
Other Study ID Numbers:
  • 20_RIPH2_22
  • 2020-A02412-37
First Posted:
Jul 2, 2021
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Center of Martinique
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022