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

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?

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Key information

Conditions

Gastric Cancer Atrophic Gastritis Digestive System Diseases Digestive System Neoplasms Dysplasia Stomach Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Infection Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Médico UC-CHRISTUS San Joaquín, Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

High grade dysplasia/Gastric adenocarcinoma

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

Agencia Nacional de Investigación y Desarrollo
European Union

Registry information

Official study 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.

Acronym: ECHOS

Important dates

Study start: 2015
Primary completion: 2021
Study completion: 2023
First posted: Aug 1, 2023
Registry last updated: Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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