Monitoring patients with precursors to gastric cancer
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
This study is testing the best ways to monitor people over 45 with early signs of stomach cancer to help keep them safe and healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 912 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Instituto Portugues de Oncologia, Francisco Gentil, Porto Academic / other |
| Locations | 1 site (Porto) |
| Trial ID | NCT04613570 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate patients with premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia, to determine the best methods for their identification and follow-up. It will utilize high-resolution endoscopy and validated histological scales to assess the risk of gastric cancer over time. The study will involve multiple gastroenterology departments across various countries and will focus on patients over 45 years old who are scheduled for upper gastrointestinal endoscopy. By analyzing clinical, histological, and endoscopic factors, the study seeks to establish optimal surveillance protocols for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 45 years old with known gastric premalignant conditions scheduled for upper GI endoscopy.
Not a fit: Patients with a history of previous gastrectomy, endoscopic resection of neoplastic lesions, or hereditary syndromes increasing gastric cancer risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surveillance strategies that reduce the risk of gastric cancer in at-risk patients.
How similar studies have performed: Other studies have shown success in using endoscopic surveillance for gastric cancer precursors, but this approach is novel in its comprehensive evaluation of multiple factors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for upper GI endoscopy with indication for gastric biopsies, including those with known gastric pathology (e.g. auto-immune gastritis) or premalignant conditions (e.g patients under surveillance because of atrophic gastritis); * Age above 45 years old Exclusion Criteria: * History of previous gastrectomy; * History of endoscopic resection of neoplastic lesion * History of previous gastric dysplasia (even with no detectable lesion) * Hereditary syndromes that increase gastric cancer risk (familial adenomatous polyposis; Lynch syndrome) * Serious comorbidities (ASA 3 or more) * Medication with anticoagulants
Where this trial is running
Porto
- IPO-Porto — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Pedro Pimentel-Nunes, MD PhD — Instituto Português de Oncologia do Porto, Francisco Gentil
- Study coordinator: Pedro Pimentel-Nunes, MD PhD
- Email: pedro.nunes@ipoporto.min-saude.pt
- Phone: +35122508400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.