Oncology EpidemiologyPyloCaGeNCT07233447
Prevalence of H. Pylori in Stomach Cancers in the West Indies
An observational study of Oncology Epidemiology and Risk Factors, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in Guadeloupe.
Trial summary
The incidence and mortality of stomach cancer are higher in the French West Indies than in mainland France. The prevalence of H. pylori infection associated with this cancer remains unknown in these populations. The main objective of the study is to estimate the prevalence of H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology Epidemiology, Risk Factors
- How many people
- 100 participants
- Where
- 2 sitesGuadeloupe
- Study dates
- 24 Feb 2025to 24 Feb 2027
- 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: Patients living in Guadeloupe for more than 6 months, referred to the gastroenterology departments of the University Hospital of Guadeloupe (CHUG) and to the gastroenterology practice of Dr. Durand, with an endoscopic diagnosis of gastric cancer confirmed by histopathological examination in one of the three endoscopy centers (CHUG, Polyclinique de la Guadeloupe, and Clinique des Eaux Claires), will be invited to participate in the study following their disclosure consultation.
Who may be able to join
- Patient over 18 years of age residing in Guadeloupe for more than 6 months and 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 scheme
- Patient under legal protection (judicial safeguard, guardianship, curatorship, etc.)
- Pregnant or breastfeeding woman
- Subject participating in another research study that includes an exclusion period still ongoing at the time of pre-inclusion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe2 sites, 2 recruiting
- Recruiting
Cabinet Galeries de Houelbourg
Baie-Mahault, 97122
Magali Durand, MD, +590590261948, durand@cabinetgastro.com
- Recruiting
CHU de la Guadeloupe
Pointe-à-Pitre, 97159
melanie petapermal, +590590934667, melanie.petapermal@chu-guadeloupe.fr
petapermal, melanie.petapermal@chu-guadeloupe.fr
About this study
The incidence and mortality of stomach cancer are higher in the French West Indies than in mainland France. The prevalence of H. pylori infection associated with this cancer remains unknown in these populations. The main objective of the study is to estimate the prevalence of H. Pylori detected by immunohistochemistry in patients newly diagnosed with cancer.
Read the detailed description
Stomach cancer is the 4th most common cancer site in the world and the 3rd cause of mortality. It is associated with infection by the Helicobacter Pylori bacterium, which colonizes the gastric mucosa in 80% of cases. The decrease of the prevalence of H. pylori infection in developed countries with the advent of antibiotic treatments is responsible for the decrease in the incidence of stomach cancer. But in the French West Indies, stomach cancer remains in excess incidence and mortality compared to France. The prevalence of H. pylori infection remains unknown, both in general population and in patients with stomach cancer. Eating habits combining high consumption of salt, meat and smoked fish could partly explain these high incidences. Furthermore, recent observations suggest that environmental risk factors (pesticides pollution) could also be involved in the occurrence of this cancer. Estimating the prevalence of H. pylori in stomach cancers will improve the epidemiological knowledge of this cancer with high incidence rates and prevention measures.
- Conditions
- Oncology Epidemiology, Risk Factors
- Keywords
- H. Pylori, Guadeloupe, stomach cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of H. Pylori in immunohistochemistry
Detection of Helicobacter pylori will be performed by immunohistochemistry (IHC) on gastric biopsy samples collected at inclusion. The procedure aims to identify the presence of H. pylori antigens within the gastric mucosa using specific antibodies. The test will be conducted in a certified pathology laboratory according to standard diagnostic protocols. Results will be reported as positive or negative for H. pylori infection.
Measured: Baseline
Secondary outcomes (1)
positivity of anti H. Hylori serology by Elisa test
Positivity of anti-Helicobacter pylori serology determined by ELISA test performed on serum samples collected at inclusion. Results will be reported as positive or negative for H. pylori antibodies.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start24 Feb 2025
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology EpidemiologyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Deloumeaux, MD PhD, Study director, CHU de la GuadeloupeMoana GELU-SIMEON, MD PhD, Study chair, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233447
- Sponsor's protocol ID
- PAP_RIPH2_2020/27
- Acronym
- PyloCaGe
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of H. Pylori in Stomach Cancers in the West Indies
- ClinicalTrials.gov ID
- NCT07233447
- Acronym / sponsor ID
- PyloCaGe / PAP_RIPH2_2020/27
- Conditions
- Oncology Epidemiology, Risk Factors
- Keywords
- H. Pylori, Guadeloupe, stomach cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Feb 2027 (estimated)
- First posted
- 18 Nov 2025 (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.
The incidence and mortality of stomach cancer are higher in the French West Indies than in mainland France. The prevalence of H. pylori infection associated with this cancer remains unknown in these populations. The main objective of the study is to estimate the prevalence of H. Pylori detected by immunohistochemistry in patients newly diagnosed with cancer.
Detailed description
Stomach cancer is the 4th most common cancer site in the world and the 3rd cause of mortality. It is associated with infection by the Helicobacter Pylori bacterium, which colonizes the gastric mucosa in 80% of cases. The decrease of the prevalence of H. pylori infection in developed countries with the advent of antibiotic treatments is responsible for the decrease in the incidence of stomach cancer. But in the French West Indies, stomach cancer remains in excess incidence and mortality compared to France. The prevalence of H. pylori infection remains unknown, both in general population and in patients with stomach cancer. Eating habits combining high consumption of salt, meat and smoked fish could partly explain these high incidences. Furthermore, recent observations suggest that environmental risk factors (pesticides pollution) could also be involved in the occurrence of this cancer. Estimating the prevalence of H. pylori in stomach cancers will improve the epidemiological knowledge of this cancer with high incidence rates and prevention measures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in Guadeloupe for more than 6 months, referred to the gastroenterology departments of the University Hospital of Guadeloupe (CHUG) and to the gastroenterology practice of Dr. Durand, with an endoscopic diagnosis of gastric cancer confirmed by histopathological examination in one of the three endoscopy centers (CHUG, Polyclinique de la Guadeloupe, and Clinique des Eaux Claires), will be invited to participate in the study following their disclosure consultation.
Key inclusion criteria (3 listed)
- Patient over 18 years of age residing in Guadeloupe for more than 6 months and 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 (6 listed)
- Refusal to participate.
- Patient who could not answer the questionnaires
- Patient not affiliated to a social security scheme
- Patient under legal protection (judicial safeguard, guardianship, curatorship, etc.)
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detection of H. Pylori in immunohistochemistry
Time frame: Baseline
Detection of Helicobacter pylori will be performed by immunohistochemistry (IHC) on gastric biopsy samples collected at inclusion. The procedure aims to identify the presence of H. pylori antigens within the gastric mucosa using specific antibodies. The test will be conducted in a certified pathology laboratory according to standard diagnostic protocols. Results will be reported as positive or negative for H. pylori infection.
1 secondary outcome
positivity of anti H. Hylori serology by Elisa test
Time frame: Baseline
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Jacqueline Deloumeaux, MD PhD study director
CHU de la Guadeloupe
Moana GELU-SIMEON, MD PhD study chair
CHU de la Guadeloupe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology Epidemiology and Risk Factors, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in Guadeloupe.
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 6 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe. 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 Mélanie petapermal, Master degree (+590590934667, melanie.petapermal@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of H. Pylori in immunohistochemistry (time frame: 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 18 Nov 2025.