Costs of Opportunistic Upper Gastrointestinal Endoscopy and the Economic Burden of Gastric Cancer Management (EconROGCAS)

April 3, 2026 updated by: Beatriz Mourato, Unidade Local De Saúde Do Norte Alentejano

Real-world Incremental Costs of Opportunistic Upper Gastrointestinal Endoscopy Added to Colorectal Cancer Screening and the Economic Burden of Gastric Cancer Management: a Retrospective Cohort Study - Study Protocol

Data will be extracted from routinely collected hospital databases.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Electronic medical records; Endoscopy and pathology databases; Surgical and hospitalization records; Oncology treatment databases; Imaging and diagnostic services; Institutional mortality records.

Study Type

Observational

Enrollment (Estimated)

250

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, 7300-060
        • Unidade Local de Saúde do Alto Alentejo

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

Cohort A - Opportunistic screening cohort A cohort of FIT-positive individuals undergoing colonoscopy for colorectal cancer screening, with the addition of opportunistic EGD during the same procedure.

Cohort B - Gastric cancer cohort A retrospective cohort including all patients diagnosed with gastric adenocarcinoma in the institution over a 10-year period.

Description

Inclusion Criteria:

Cohort A:

  • Eligible participants were adults aged 50 to 75 years or older who had been referred for colonoscopy as part of the national colorectal cancer screening programme, following a positive FIT. To be included, individuals also needed to provide informed consent and agree to undergo an EGD endoscopy for the screening of potential upper gastrointestinal precancerous conditions or lesions.

Cohort B:

  • Patients with gastric adenocarcinoma, diagnosed and treated at Unidade Local de Saúde do Alto Alentejo between 2015 and 2020.

Exclusion Criteria:

Cohort A:

  • Exclusion criteria included a prior diagnosis of gastric cancer, as well as any condition that would prevent the safe performance of the EGD or the collection of gastric mucosal biopsies. Previous EGD was not listed as an exclusion criterion.

Cohort B:

  • Other types of gastric tumors.
  • Gastric involvement from metastatic disease of another primary tumor.

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
Cohort A - Opportunistic screening cohort
Cohort B - Gastric cancer cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage distribution at diagnosis
Time Frame: At diagnosis (2015-2020)
Distribution of gastric cancer stages at diagnosis (Stage I-IV) according to TNM classification (expressed as percentage of patients per stage).
At diagnosis (2015-2020)
Treatment patterns
Time Frame: During initial treatment period (2015-2020)
Types of treatment received by patients with gastric cancer, including surgery, chemotherapy, radiotherapy, and palliative care
During initial treatment period (2015-2020)
Overall survival
Time Frame: From diagnosis up to last follow-up (2015-2020)
Overall survival of patients diagnosed with gastric cancer (measured in months).
From diagnosis up to last follow-up (2015-2020)

Collaborators and Investigators

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

Sponsor

Unidade Local De Saúde Do Norte Alentejano

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

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)

January 2, 2026

Primary Completion (Estimated)

April 3, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (033)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication on index journal

IPD Sharing Time Frame

2015 to 2020

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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