Gastric Cancer Endoscopic Screening in an Intermediate-risk Country - ROGCAS, a Dual-centre Pilot Program (ROGCAS)

February 24, 2025 updated by: Beatriz Mourato, Unidade Local De Saúde Do Norte Alentejano

ROGCAS - Retrospective Observational Gastric Cancer Study

Endoscopic screening of gastric cancer combined with screening colonoscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an observational retrospective research entitled "Gastric cancer endoscopic screening in an intermediate-risk country - ROGCAS, a dual-centre pilot program" (STROBE protocol. This study will analyze the results of an initiative of the ULSAALE Endoscopy Units, which, with the approval of the Board of Directors and Ethics Committee, started an opportunistic screening pilot program for oesophagogastric cancer in February 2023, inviting users from the national colorectal screening program to undergo EGD at the same time as screening colonoscopy. Based on the assumptions of the theoretical models of cost-effectiveness studies, we will analyze the efficacy of endoscopic screening for GC by determining the HP infection rate, the pre-malignant lesion detection rate, the GC detection rate, the early GC detection rate, the stage at diagnosis, the adherence rate and the cost of this pilot program. This study will be carried out in the Endoscopy Units of Hospital Doutor José Maria Grande and Hospital de Santa Luzia de Elvas, with the approval of the Board of Directors and the Ethics Committee of ULSAALE, and data will be collected by consulting the Sclinico records of patients who agree to participate in the study and who have undergone EGD and screening colonoscopy at the same time in these hospitals. In terms of potential benefits, this study could help to elucidate the appropriateness of introducing endoscopic GC screening at the same time as colorectal cancer screening in order to detect pre-malignant and malignant lesions at an earlier stage, thus improving the management and prognosis of this pathology.

On the other hand, users can undergo two endoscopic screenings simultaneously with the same sedation, saving time and resources and reducing the number of referrals to health centers. In terms of risks, there are those associated with endoscopic procedure and those associated with the screening process. As for complications, although rare, bleeding, perforation and infection have been described, but ULSAALE has expert teams of gastroenterologists and surgeons to deal with these complications. There are also risks associated with the sedation process, related to local and systemic pharmacological reactions and the possible need for ventilatory support, which is why an anaesthesiologist and/or an advanced life support team is always present. The risks of the screening program itself are related to false positive results and overdiagnosis. False positives, in addition to the potential psychological damage to the patient, lead to unnecessary diagnostic investigations and consumption of resources. Overdiagnosis, on the other hand, could place a burden on health services, both in terms of surveillance of premalignant lesions and in terms of providing timely treatment to patients diagnosed with GC. However, since this is a pathology with a high incidence and mortality rate in Portugal, the benefits of early diagnosis and improved prognosis seem to outweigh the inherent risks of the endoscopic screening program. Participation in this study is also voluntary and all participants will be asked to give informed consent after receiving adequate information and personal reflection.

Study Type

Observational

Enrollment (Actual)

349

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Portalegre, Portugal, 7300-853
        • ULSNA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy people proposed to undergo colonoscopy to screen for colorectal cancer after a positive fecal occult blood test, through the national colorectal cancer screening program and who agreed to undergo endoscopy to screen for esophagogastric lesions

Description

Inclusion Criteria:

  • people who agree to undergo endoscopic screening for gastric cancer;
  • people who undergo screening colonoscopy

Exclusion Criteria:

  • Exams without biopsies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
screening endoscopy
We perform upper endoscopy, when the patient authorizes it, at the same time of their screening colonoscopy
Diagnostic test: Screening endoscopy
We perform upper endoscopy, when the patient authorizes it, during their screening colonoscopy
Other Names:
  • upper endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of gastric adenocarcinoma
Time Frame: 1 month
number of gastric adenocarcinomas detected in patients undergoing opportunistic endoscopic screening, confirmed by histological examination of biopsies obtained during the screening endoscopic examination
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of pre-malignant lesions
Time Frame: 1 month
number of cases of intestinal metaplasia or atrophic gastritis detected in the histological examination of biopsies obtained during endoscopic screening
1 month
Costs of screening endoscopy
Time Frame: 1 year
costs in euros of each endoscopic examination in addition to the base cost of the scheduled colonoscopy screening
1 year
Socio-demographic characteristics of population in screening program
Time Frame: 1 month
Determine the correlation between the socio-demographic characteristics of patients and the detection of gastric cancer by opportunistic screening
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidade Local De Saúde Do Norte Alentejano

Collaborators

NOVA Medical School
Universidade Nova de Lisboa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

February 24, 2025

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROGCAS
  • ROGCAS Study (Other Identifier: ULSNA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Endoscopic images; endoscopy reports; histopathology reports

IPD Sharing Time Frame

end of study

IPD Sharing Access Criteria

investigators of other clinical trials and systematic reviews

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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