SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up

Gastric Cancer Clinical Trial

— SUPREME  

Official title:

SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613570
• Other study ID #: SUPREME
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2022
• Source: Instituto Portugues de Oncologia, Francisco Gentil, Porto
• Contact: Pedro Pimentel-Nunes, MD PhD
• Phone: +35122508400
• Email: pedro.nunes[@]ipoporto.min-saude.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 912
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastric Cancer
• Gastric Dysplasia
• Gastritis
• Gastritis, Atrophic
• Intestinal Metaplasia
• Metaplasia
• Precancerous Conditions
• Stomach Neoplasms

Intervention

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;

Locations

Country	Name	City	State
Portugal	IPO-Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Portugues de Oncologia, Francisco Gentil, Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysplasia	Proportion of patients with dysplasia (low or high-grade)	6 years
Primary	Carcinoma	Proportion of patients with gastric adenocarcinoma	6 years
Secondary	Curative criteria	Proportion of patients with intramucosal carcinoma with low-risk criteria ("curative" criteria)	6 years
Secondary	Non-curative criteria	Proportion of patients with submucosal, diffuse type or intramucosal carcinoma with high-risk criteria ("non-curative" criteria)	6 years
Secondary	Advanced gastric cancer	Proportion of patients with advanced gastric cancer (without indication for endoscopic treatment)	6 years