- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04949737
Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies (Hélico-MQ)
Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies: Helico-MQ Interventional Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clarisse JOACHIM-CONTARET
- Phone Number: +596596559674
- Email: clarisse.joachim@chu-martinique.fr
Study Contact Backup
- Name: Mickaelle ROSE
- Phone Number: +596596592623
- Email: mickaelle.rose@chu-martinique.fr
Study Locations
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-
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Fort-de-France, Martinique, 97261
- Recruiting
- CHU Martinique
-
Principal Investigator:
- Thierry BORTUZZO
-
Contact:
- Mickaelle ROSE
- Phone Number: +596596592623
- Email: mickaelle.rose@chu-martinique.fr
-
Principal Investigator:
- Amélie BIRON
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimation of the prevalence of Helicobacter pylori
Time Frame: At baseline
|
Helicobacter Pylori has detected by immunohistochemistry in the stomach of patients with gastric cancer.
|
At baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Clarisse JOACHIM-CONTARET, CHU Martinique
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20_RIPH2_22
- 2020-A02412-37 (Other Identifier: DGS, Ministry of Health)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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