Endoscopic Surveillance on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.
ECHOS
The Impact of Endoscopic Surveillance of Atrophic Gastritis With and Without Intestinal Metaplasia on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.
1 other identifier
observational
685
1 country
2
Brief Summary
The goal of this observational study is to evaluate the risk factors associated with incident HGD/GA in patients with CAG with or without IM who are enrolled in endoscopic surveillance, as well as to compare GA incidence according to the OLGA and OLGIM scales in patients 18 years or older. . The main questions it aims to answer are:
- What risk factors are associated with incident HGD/GA in patients with CAG with or without IM?
- What is the comparative HGD/GA incidence according to the OLGA and OLGIM scales?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2023
CompletedFirst Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedAugust 1, 2023
June 1, 2023
6.1 years
June 28, 2023
July 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
High grade dysplasia/Gastric adenocarcinoma
Progression from chronic atrophic gastritis or intestinal metaplasia according to baseline Operative Link on Gastritis Assessment (OLGA) staging in baseline measurement to high-grade dysplasia and adenocarcinoma. The OLGA uses grades from in tiered scale from 0 to IV, resulting from the combination of atrophic changes (0 = absent; 1 = mild; 2 = moderate; 3 = severe) in the two mucosal compartments (antrum and corpus).
At least 6 months between first and second EGD, assessed up to 96 months
Eligibility Criteria
Patients atteding an EGD at Pontificia Universidad Católica de Chile health care system, an open health care system with three endoscopic units in Santiago, Chile.
You may qualify if:
- At least one non-urgent outpatient esophagogastroduodenoscopy (EGD) with gastric biopsies collected following the Updated Sydney System Biopsy Protocol (USSBP) between June 2015 and June 2021.
- Underwent a subsequent "surveillance" EGD. For the subsequent EGD to qualify as surveillance, it needed to occur at least six months after the baseline EGD and include gastric biopsies collected according to the USSBP; one exception to the USSBP requirement was if HGD or GA was detected on the surveillance.
You may not qualify if:
- Prior history of HGD or any type of gastric malignancy, gastrectomy, or non-gastric active malignancy.
- HGD or GA on the baseline EGD was excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pontificia Universidad Catolica de Chilelead
- Agencia Nacional de Investigación y Desarrollocollaborator
- European Unioncollaborator
Study Sites (2)
Centro de especialidades médicas Marcoleta UC CHRISTUS
Santiago, Santiago Metropolitan, Chile
Centro Médico UC-CHRISTUS San Joaquín
Santiago, Santiago Metropolitan, Chile
Biospecimen
Gastric mucosa biopsies were obtained following the USSBP as follows: * Two tissue samples obtained from the antrum (within 2 to 3 cm from the pylorus, from lesser and greater curvature) * One sample from the incisura angularis * Two samples from the body (one from lesser curvature, \~4 cm proximal from the angle,e and one from greater curvature, \~8 cm distal to cardia) * Samples from each anatomical location were collected either directed to a suspicious endoscopic finding of CAG or IM or following anatomical reference of the protocol if apparently normal gastric mucosa was visualized
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2023
First Posted
August 1, 2023
Study Start
June 1, 2015
Primary Completion
June 30, 2021
Study Completion
March 6, 2023
Last Updated
August 1, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share