Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613570
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Diogo Libânio, Instituto Portugues de Oncologia, Francisco Gentil, Porto

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment Phase
Atrophic Gastritis Intestinal Metaplasia Gastric Dysplasia Gastric Cancer Diagnostic Test: Upper gastrointestinal endoscopy Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 912 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
Actual Study Start Date : January 2, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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;
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;


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dysplasia [ Time Frame: 6 years ]
    Proportion of patients with dysplasia (low or high-grade)

  2. Carcinoma [ Time Frame: 6 years ]
    Proportion of patients with gastric adenocarcinoma


Secondary Outcome Measures :
  1. Curative criteria [ Time Frame: 6 years ]
    Proportion of patients with intramucosal carcinoma with low-risk criteria ("curative" criteria)

  2. Non-curative criteria [ Time Frame: 6 years ]
    Proportion of patients with submucosal, diffuse type or intramucosal carcinoma with high-risk criteria ("non-curative" criteria)

  3. Advanced gastric cancer [ Time Frame: 6 years ]
    Proportion of patients with advanced gastric cancer (without indication for endoscopic treatment)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613570


Contacts
Layout table for location contacts
Contact: Pedro Pimentel-Nunes, MD PhD +35122508400 ext 3348 pedro.nunes@ipoporto.min-saude.pt
Contact: Diogo Libanio, MD PhD +35122508400 ext 7442 diogo.monteiro@ipoporto.min-saude.pt

Locations
Layout table for location information
Portugal
IPO-Porto Recruiting
Porto, Portugal, 4200-072
Contact: Diogo Libanio, MD PhD    +351910288892    diogo.monteiro@ipoporto.min-saude.pt   
Contact: Pedro Nunes, MD PhD    +351967340096    pedro.nunes@ipoporto.min-saude.pt   
Sponsors and Collaborators
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Investigators
Layout table for investigator information
Principal Investigator: Pedro Pimentel-Nunes, MD PhD Instituto Português de Oncologia do Porto, Francisco Gentil
  Study Documents (Full-Text)

Documents provided by Diogo Libânio, Instituto Portugues de Oncologia, Francisco Gentil, Porto:
Study Protocol  [PDF] June 4, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Diogo Libânio, Principal Investigator, Instituto Portugues de Oncologia, Francisco Gentil, Porto
ClinicalTrials.gov Identifier: NCT04613570    
Other Study ID Numbers: SUPREME
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diogo Libânio, Instituto Portugues de Oncologia, Francisco Gentil, Porto:
atrophic gastritis
gastric cancer
intestinal metaplasia
gastric dysplasia
surveillance
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Precancerous Conditions
Gastritis
Gastritis, Atrophic
Atrophy
Metaplasia
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis
Pathological Conditions, Anatomical
Pathologic Processes