Atrophic GastritisSUPREMENCT04613570
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
A study testing Upper gastrointestinal endoscopy in people with Atrophic Gastritis and Intestinal Metaplasia, run by Instituto Portugues de Oncologia, Francisco Gentil, Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Atrophic Gastritis, Intestinal Metaplasia, Gastric Dysplasia
- What is being tested?
- Upper gastrointestinal endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2021to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
IPO-Porto
Porto, 4200-072
Diogo Libanio, MD PhD, +351910288892, diogo.monteiro@ipoporto.min-saude.pt
Pedro Nunes, MD PhD, +351967340096, pedro.nunes@ipoporto.min-saude.pt
About this study
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).
Read the 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).
- Being tested
- Upper gastrointestinal endoscopy
- Keywords
- atrophic gastritis, gastric cancer, intestinal metaplasia, gastric dysplasia, surveillance
- Medical subject headings
- Gastritis, Atrophic, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper gastrointestinal endoscopyDiagnostic test
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;
| Study group | Role | What they receive |
|---|---|---|
| Yearly endoscopy | Experimental | Upper gastrointestinal endoscopy every year (12-16 months) Receives: Diagnostic Test: Upper gastrointestinal endoscopy |
| Endoscopy every 3 years | Other | Upper gastrointestinal endoscopy every three years (32-40 months) Receives: Diagnostic Test: Upper gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysplasia
Proportion of patients with dysplasia (low or high-grade)
Measured: 6 years
Carcinoma
Proportion of patients with gastric adenocarcinoma
Measured: 6 years
Secondary outcomes (3)
Curative criteria
Proportion of patients with intramucosal carcinoma with low-risk criteria ("curative" criteria)
Measured: 6 years
Non-curative criteria
Proportion of patients with submucosal, diffuse type or intramucosal carcinoma with high-risk criteria ("non-curative" criteria)
Measured: 6 years
Advanced gastric cancer
Proportion of patients with advanced gastric cancer (without indication for endoscopic treatment)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start2 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with EGGIM \> 5 or OLGA/OLGIM III/IV (premalignant stomach group - SUPREME I) will be randomized to endoscopic surveillance every one (12 to 16 months) or three years (32-40 months);
- Masking
- None (open label)
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diogo Libânio, Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Investigators
- Pedro Pimentel-Nunes, MD PhD, Principal investigator, Instituto Português de Oncologia do Porto, Francisco Gentil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613570
- Sponsor's protocol ID
- SUPREME
- Acronym
- SUPREME
- Status last verified
- Mar 2022
- First submitted
- 16 Oct 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No