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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
- ClinicalTrials.gov ID
- NCT04613570
- Acronym / sponsor ID
- SUPREME / SUPREME
- Keywords
- atrophic gastritis, gastric cancer, intestinal metaplasia, gastric dysplasia, surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Instituto Portugues de Oncologia, Francisco Gentil, PortoUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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);
| Arm | Type | Receives |
|---|---|---|
| Yearly endoscopy | Experimental | Diagnostic Test: Upper gastrointestinal endoscopyUpper gastrointestinal endoscopy every year (12-16 months) |
| Endoscopy every 3 years | Other | Diagnostic Test: Upper gastrointestinal endoscopyUpper gastrointestinal endoscopy every three years (32-40 months) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper gastrointestinal endoscopyIn 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; | Diagnostic test | Endoscopy every 3 years, Yearly endoscopy |
Primary outcome
Dysplasia
Time frame: 6 years
Proportion of patients with dysplasia (low or high-grade)
Carcinoma
Time frame: 6 years
Proportion of patients with gastric adenocarcinoma
3 secondary outcomes
Curative criteria
Time frame: 6 years
Non-curative criteria
Time frame: 6 years
Advanced gastric cancer
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Atrophic Gastritis
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
RecruitingObservational study
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis
Gastric Cancer, Intestinal Metaplasia
Active, not recruitingPhase 2
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Chronic Atrophic Gastritis, Gastric Carcinoma
Enrolling by invitationObservational study
UC Davis Cohort of Pre-Malignant and Malignant Gastro-Intestinal DisEases Study
Intestinal Metaplasia, Chronic Gastritis
RecruitingObservational study
The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
Functional Dyspepsia, Gastritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro Pimentel-Nunes, MD PhD principal investigator
Instituto Português de Oncologia do Porto, Francisco Gentil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Pimentel-Nunes, MD PhD (+35122508400 ext. 3348, pedro.nunes@ipoporto.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysplasia (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.