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

Gastric Cancer Clinical Trial

— ECHOS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05969444
• Other study ID #: 1230504 (AR)
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: March 6, 2023

Study information

• Verified date: June 2023
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: March 6, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Gastric Cancer
• Gastritis
• Gastritis, Atrophic
• Helicobacter Pylori Infection
• Stomach Neoplasms

Locations

Country	Name	City	State
Chile	Centro de especialidades médicas Marcoleta UC CHRISTUS	Santiago	Región Metropolitana
Chile	Centro Médico UC-CHRISTUS San Joaquín	Santiago	Metropolitana

Sponsors (3)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Agencia Nacional de Investigación y Desarrollo, European Union

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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