Gastric Cancer (GC)EconROGCASNCT07522320
Costs of Opportunistic Upper Gastrointestinal Endoscopy and the Economic Burden of Gastric Cancer Management
An observational study of Gastric Cancer (GC) and Gastric Adenocarcinoma, run by Unidade Local De Saúde Do Norte Alentejano at 1 site in Portugal.
Trial summary
Data will be extracted from routinely collected hospital databases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer (GC), Gastric Adenocarcinoma
- How many people
- 250 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2026to 21 Jul 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 11-year period.
Who may be able to join
- 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 2025.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Electronic medical records; Endoscopy and pathology databases; Surgical and hospitalization records; Oncology treatment databases; Imaging and diagnostic services; Institutional mortality records.
- Conditions
- Gastric Cancer (GC), Gastric Adenocarcinoma
- Keywords
- Screening, Gastric Cancer, economic
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Opportunistic screening cohort | Cohort B - Gastric cancer cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage distribution at diagnosis
Distribution of gastric cancer stages at diagnosis (Stage I-IV) according to TNM classification (expressed as percentage of patients per stage).
Measured: At diagnosis (2015-2020)
Treatment patterns
Types of treatment received by patients with gastric cancer, including surgery, chemotherapy, radiotherapy, and palliative care
Measured: During initial treatment period (2015-2020)
Overall survival
Overall survival of patients diagnosed with gastric cancer (measured in months).
Measured: From diagnosis up to last follow-up (2015-2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Jan 2026
- Primary completion21 Jul 2026 (estimated)
- Study completion21 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Unidade Local De Saúde Do Norte Alentejano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Mourato, Unidade Local De Saúde Do Norte Alentejano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522320
- Sponsor's protocol ID
- 003
- Other IDs
- 003
- Acronym
- EconROGCAS
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication on index journal
Publications
Areia M, Spaander MC, Kuipers EJ, Dinis-Ribeiro M. Endoscopic screening for gastric cancer: A cost-utility analysis for countries with an intermediate gastric cancer risk. United European Gastroenterol J. 2018 Mar;6(2):192-202. doi: 10.1177/2050640617722902. Epub 2017 Jul 18.
PubMed 29511549Lansdorp-Vogelaar I, Meester RGS, Laszkowska M, Escudero FA, Ward ZJ, Yeh JM. Cost-effectiveness of prevention and early detection of gastric cancer in Western countries. Best Pract Res Clin Gastroenterol. 2021 Mar-Apr;50-51:101735. doi: 10.1016/j.bpg.2021.101735. Epub 2021 Feb 22.
PubMed 33975689Mourato MB, Pratas N, Branco Pereira A, Tare F, Chanca R, Fronteira I, Dinis R, Areia M. Effectiveness of Gastric Cancer Endoscopic Screening in Intermediate-Risk Countries: Protocol for a Systematic Review and Meta-Analysis. JMIR Res Protoc. 2025 Feb 3;14:e56791. doi: 10.2196/56791.
PubMed 39545590Mourato MB, Pratas N, Branco Pereira A, Costa Pinto F, Dinis R, Fronteira I, Areia M. Gastric Cancer Endoscopic Screening in an Intermediate-Risk Country-A Dual-Center Pilot Program. Helicobacter. 2025 Jul-Aug;30(4):e70061. doi: 10.1111/hel.70061.
PubMed 40762368Ishii N, Shiratori Y, Ishikane M, Omata F. Population effectiveness of endoscopy screening for mortality reduction in gastric cancer. DEN Open. 2023 Sep 19;4(1):e296. doi: 10.1002/deo2.296. eCollection 2024 Apr.
PubMed 37731836Mourato B, Pinto P, Vieira J, Vidinha M, Carvalho V, Pratas N, Capote H, Fronteira I, Dinis R, Areia M. Opportunistic Gastric Cancer Endoscopic Screening Integrated Into Population-Based Colorectal Cancer Screening: A Retrospective Economic Cost-Comparison Study. Helicobacter. 2026 Sep-Oct;31(5):e70161. doi: 10.1111/hel.70161.
PubMed 42830480
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07522320
- Acronym / sponsor ID
- EconROGCAS / 003
- Conditions
- Gastric Cancer (GC), Gastric Adenocarcinoma
- Keywords
- Screening, Gastric Cancer, economic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Unidade Local De Saúde Do Norte AlentejanoUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 21 Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data will be extracted from routinely collected hospital databases.
Detailed description
Electronic medical records; Endoscopy and pathology databases; Surgical and hospitalization records; Oncology treatment databases; Imaging and diagnostic services; Institutional mortality records.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Opportunistic screening cohort | – | –Cohort B - Gastric cancer cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 11-year period.
Key inclusion criteria (4 listed)
- 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.
- Patients with gastric adenocarcinoma, diagnosed and treated at Unidade Local de Saúde do Alto Alentejo between 2015 and 2025.
Key exclusion criteria (5 listed)
- 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.
- Other types of gastric tumors.
- Gastric involvement from metastatic disease of another primary tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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
Overall survival
Time frame: From diagnosis up to last follow-up (2015-2020)
Overall survival of patients diagnosed with gastric cancer (measured in months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 29511549Areia M, Spaander MC, Kuipers EJ, Dinis-Ribeiro M. Endoscopic screening for gastric cancer: A cost-utility analysis for countries with an intermediate gastric cancer risk. United European Gastroenterol J. 2018 Mar;6(2):192-202. doi: 10.1177/2050640617722902. Epub 2017 Jul 18.
- Background: PubMed 33975689Lansdorp-Vogelaar I, Meester RGS, Laszkowska M, Escudero FA, Ward ZJ, Yeh JM. Cost-effectiveness of prevention and early detection of gastric cancer in Western countries. Best Pract Res Clin Gastroenterol. 2021 Mar-Apr;50-51:101735. doi: 10.1016/j.bpg.2021.101735. Epub 2021 Feb 22.
- Background: PubMed 39545590Mourato MB, Pratas N, Branco Pereira A, Tare F, Chanca R, Fronteira I, Dinis R, Areia M. Effectiveness of Gastric Cancer Endoscopic Screening in Intermediate-Risk Countries: Protocol for a Systematic Review and Meta-Analysis. JMIR Res Protoc. 2025 Feb 3;14:e56791. doi: 10.2196/56791.
- Background: PubMed 40762368Mourato MB, Pratas N, Branco Pereira A, Costa Pinto F, Dinis R, Fronteira I, Areia M. Gastric Cancer Endoscopic Screening in an Intermediate-Risk Country-A Dual-Center Pilot Program. Helicobacter. 2025 Jul-Aug;30(4):e70061. doi: 10.1111/hel.70061.
- Background: PubMed 37731836Ishii N, Shiratori Y, Ishikane M, Omata F. Population effectiveness of endoscopy screening for mortality reduction in gastric cancer. DEN Open. 2023 Sep 19;4(1):e296. doi: 10.1002/deo2.296. eCollection 2024 Apr.
- Derived from this study: PubMed 42830480Mourato B, Pinto P, Vieira J, Vidinha M, Carvalho V, Pratas N, Capote H, Fronteira I, Dinis R, Areia M. Opportunistic Gastric Cancer Endoscopic Screening Integrated Into Population-Based Colorectal Cancer Screening: A Retrospective Economic Cost-Comparison Study. Helicobacter. 2026 Sep-Oct;31(5):e70161. doi: 10.1111/hel.70161.
- Individual participant dataSharing planned: Yes. Publication on index journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (GC) and Gastric Adenocarcinoma, run by Unidade Local De Saúde Do Norte Alentejano at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage distribution at diagnosis (time frame: At diagnosis (2015-2020)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522320, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.