SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up (SUPREME)

March 29, 2022 updated by: Diogo Libânio, Instituto Portugues de Oncologia, Francisco Gentil, Porto

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

912

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yearly endoscopy
Upper gastrointestinal endoscopy every year (12-16 months)
Diagnostic test: Upper 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;
Other: Endoscopy every 3 years
Upper gastrointestinal endoscopy every three years (32-40 months)
Diagnostic test: Upper 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysplasia
Time Frame: 6 years
Proportion of patients with dysplasia (low or high-grade)
6 years
Carcinoma
Time Frame: 6 years
Proportion of patients with gastric adenocarcinoma
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Curative criteria
Time Frame: 6 years
Proportion of patients with intramucosal carcinoma with low-risk criteria ("curative" criteria)
6 years
Non-curative criteria
Time Frame: 6 years
Proportion of patients with submucosal, diffuse type or intramucosal carcinoma with high-risk criteria ("non-curative" criteria)
6 years
Advanced gastric cancer
Time Frame: 6 years
Proportion of patients with advanced gastric cancer (without indication for endoscopic treatment)
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Investigators

  • Principal Investigator: Pedro Pimentel-Nunes, MD PhD, Instituto Portugues de Oncologia do Porto, Francisco Gentil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2021

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUPREME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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