Stomach NeoplasmsHélico-MQNCT04949737
Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies
An observational study of Stomach Neoplasms and Gastric Neoplasms, run by University Hospital Center of Martinique at 1 site in Martinique.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Gastric Neoplasms, Helicobacter Pylori
- What is being tested?
- Helicobacter Pylori detection
- How many people
- 112 participants
- Where
- 1 siteMartinique
- Study dates
- 9 Oct 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martinique1 site, 1 recruiting
- Recruiting
CHU Martinique
Fort-de-France, 97261
Mickaelle ROSE, +596596592623, mickaelle.rose@chu-martinique.fr
Amélie BIRON
About this study
Official title: Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies: Helico-MQ Interventional Study
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.
Read the 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.
- Conditions
- Stomach Neoplasms, Gastric Neoplasms, Helicobacter Pylori
- Being tested
- Helicobacter Pylori detection
- Keywords
- Helicobacter Pylori, Gastric cancer, Prevalence, French West-Indies
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter Pylori detectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Helicobacter Pylori detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the prevalence of Helicobacter pylori
Helicobacter Pylori has detected by immunohistochemistry in the stomach of patients with gastric cancer.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start9 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarisse JOACHIM-CONTARET, Principal investigator, CHU Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949737
- Sponsor's protocol ID
- 20_RIPH2_22
- Other IDs
- 2020-A02412-37
- Acronym
- Hélico-MQ
- Status last verified
- Mar 2026
- First submitted
- 16 Jun 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Helicobacter Pylori Infection and Gastric Cancer in the West Indies: Helico-MQ Interventional Study
- ClinicalTrials.gov ID
- NCT04949737
- Acronym / sponsor ID
- Hélico-MQ / 20_RIPH2_22
- Conditions
- Stomach Neoplasms, Gastric Neoplasms, Helicobacter Pylori
- Keywords
- Helicobacter Pylori, Gastric cancer, Prevalence, French West-Indies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helicobacter Pylori detection | – | Biological: Helicobacter Pylori detectionSystematic 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helicobacter Pylori detectionBiopsies 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. | Biological | Helicobacter Pylori detection |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clarisse JOACHIM-CONTARET principal investigator
CHU Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Gastric Neoplasms, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clarisse JOACHIM-CONTARET (+596596559674, clarisse.joachim@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the prevalence of Helicobacter pylori (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.