An observational study in Oncology Epidemiology and Risk Factors, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 2 sites in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational
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.
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 100 is below the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
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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.
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Exclusion Criteria:
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.
Time frame: Baseline
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.
Time frame: Baseline
Plan to share: No
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Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.
Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 24 months is below that.
Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.
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Centre Hospitalier Universitaire de la Guadeloupe