NCT04613570 SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
| NCT ID | NCT04613570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Portugues de Oncologia, Francisco Gentil, Porto |
| Condition | Atrophic Gastritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 912 participants |
| Start Date | 2021-01-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 912 participants in total. It began in 2021-01-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Gastric atrophy and intestinal metaplasia are the principal precursors for gastric cancer and, therefore, are considered gastric premalignant conditions. Although current guidelines recommend surveillance of individuals with these conditions, the best method for its identification and staging (histological vs endoscopy) and the best time schedule for follow-up are still controversial. Aims: To describe for the first-time patients with premalignant conditions both clinically (familial history), histologically (OLGA/OLGIM; complete/incomplete metaplasia) and endoscopically (EGGIM) using validated scales and to describe evolution of these parameters through time. To estimate prospectively the gastric cancer risk according to EGGIM stages. To define the best endoscopic surveillance follow-up for the several stages considering clinical, histological and endoscopic factors. Methods: Multicenter study involving different gastroenterology departments from several countries. Consecutive patients older than 45 years scheduled for upper endoscopy in each of these centers will be evaluated by High-Resolution- endoscopy with virtual chromoendoscopy and EGGIM will be calculated. Guided biopsies (if areas suspicious of IM) and/or random biopsies (if no areas suspicious of IM) in antrum and corpus will be made and OLGA/OLGIM stages calculated. Patients will be evaluated in clinical consultation and database will be fulfilled. All patients will be eradicated for Helicobacter pylori infection if positive. At that occasion, all the patients with EGGIM\>5 and/or OLGA III/IV and/or OLGIM III/IV will be randomized for yearly (12 to 16 months) or every three years (32-40 months) endoscopic follow-up during a period of 6 years (SUPREME I). Endoscopic observational follow-up will be scheduled for patients with EGGIM 1-4 and OLGIM I/II at 3 and 6 years (SUPREME II). For individuals with no evidence of IM (EGGIM 0 and OLGIM 0, OLGA 0-II) a follow-up endoscopy 6 years after will be proposed (SUPREME III).
Eligibility 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
Contact & Investigator
Pedro Pimentel-Nunes, MD PhD
PRINCIPAL INVESTIGATOR
Instituto Português de Oncologia do Porto, Francisco Gentil
Frequently Asked Questions
Who can join the NCT04613570 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Atrophic Gastritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04613570 currently recruiting?
Yes, NCT04613570 is actively recruiting participants. Contact the research team at pedro.nunes@ipoporto.min-saude.pt for enrollment information.
Where is the NCT04613570 trial being conducted?
This trial is being conducted at Porto, Portugal.
Who is sponsoring the NCT04613570 clinical trial?
NCT04613570 is sponsored by Instituto Portugues de Oncologia, Francisco Gentil, Porto. The principal investigator is Pedro Pimentel-Nunes, MD PhD at Instituto Português de Oncologia do Porto, Francisco Gentil. The trial plans to enroll 912 participants.