RecruitingNot ApplicableNCT04613570

SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up


Sponsor

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Enrollment

912 participants

Start Date

Jan 2, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study (called SUPREMACY) is testing a new approach to personalize surveillance schedules for patients with early stomach changes that could develop into cancer over time (called premalignant conditions like atrophic gastritis). Instead of one-size-fits-all follow-up endoscopies, it aims to tailor check-up intervals based on individual risk. **You may be eligible if...** - You are 45 years old or older - You are scheduled for an upper GI endoscopy with stomach biopsies - You have known or suspected precancerous stomach changes (such as atrophic gastritis or autoimmune gastritis) **You may NOT be eligible if...** - You have had part or all of your stomach surgically removed - You have had an endoscopic procedure to remove a cancerous or precancerous lesion - You previously had stomach cell abnormalities (dysplasia) - You have a hereditary syndrome that increases stomach cancer risk (like Lynch syndrome or familial polyposis) - You have serious other medical conditions (ASA class 3 or higher) - You take blood thinners (anticoagulants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTUpper gastrointestinal endoscopy

In all patient's complete gastroscopy first with White light and then with virtual chromoendoscopy will be made; * Suspicious lesions with dysplasia/cancer will be biopsied 1-2 fragments in a different vial; if an irregular area of mucosa (pattern C) with no clearly defined lesion then 1-2 guided biopsies fragments will be taken and sent in a different vial; * EGGIM (Endoscopic Grading of Gastric Intestinal Metaplasia) will be calculated according to previous description of this classification: * If EGGIM 0 (no endoscopically apparent IM) biopsies will be made in antrum, incisura and corpus according to Sydney-Houston protocol; * If EGGIM 1 or more guided biopsies of suspicious areas of IM should be made replacing the random biopsies in that particular area; * Antrum, incisura and corpus fragments should be sent in 3 separate vials;


Locations(1)

IPO-Porto

Porto, Portugal

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04613570


Related Trials