Endoscopic Surveillance on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Completed
CT.gov ID
NCT05969444
Collaborator
Agencia Nacional de Investigación y Desarrollo (Other), European Union (Other)
685
2
93.1
342.5
3.7

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Endoscopic Cohort and Histological OLGA staging (ECHOS) study is a retrospective longitudinal cohort developed in the Pontificia Universidad Católica de Chile health care system, an open health care system with 3 endoscopic units in Santiago, Chile. Patients 18 years or older were eligible for the study if they had at least one non-urgent outpatient EGD with gastric biopsies collected following the USSBP between June 2015 and June 2021. The baseline EGD was defined as the earliest examination conducted between this time frame that met inclusion criteria. Participants were included in the cohort if they underwent a subsequent "surveillance" EGD. In order for the subsequent EGD to qualify as surveillance, it needed to occur at least 6 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 (i.e. non-baseline) EGD. Patients with prior history of HGD or any type of gastric malignancy, gastrectomy or non-gastric active malignancy were excluded. Also, patients with HGD or GA on the baseline EGD were excluded. Patients with indefinite (IND) or low-grade dysplasia (LGD) on the baseline EGD were considered for the cohort.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    685 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    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.
    Actual Study Start Date :
    Jun 1, 2015
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Mar 6, 2023

    Outcome Measures

    Primary Outcome Measures

    1. High grade dysplasia/Gastric adenocarcinoma [At least 6 months between first and second EGD, assessed up to 96 months]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro Médico UC-CHRISTUS San Joaquín Santiago Metropolitana Chile
    2 Centro de especialidades médicas Marcoleta UC CHRISTUS Santiago Región Metropolitana Chile

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile
    • Agencia Nacional de Investigación y Desarrollo
    • European Union

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT05969444
    Other Study ID Numbers:
    • 1230504 (AR)
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2023