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Gastric CancerROGCASNCT06316882

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

An observational study of Gastric Cancer and Gastric (Stomach) Cancer, run by Unidade Local De Saúde Do Norte Alentejano at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Endoscopic screening of gastric cancer combined with screening colonoscopy Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
What is being tested?
Screening endoscopy
How many people
349 participants
Where
1 sitePortugal
Study dates
3 Feb 2023to 24 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Exams without biopsies

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • ULSNA

    Portalegre, Portalegre District, 7300-853

Other trials in Portugal

About this study

Official title: ROGCAS - Retrospective Observational Gastric Cancer Study

Endoscopic screening of gastric cancer combined with screening colonoscopy

Read the 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.

Being tested
Screening endoscopy
Keywords
Gastric Cancer, Endoscopic screening, intermediated risk countries
Medical subject headings
Stomach Neoplasms, Gastritis, Atrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening endoscopyDiagnostic test

    Also called upper endoscopy

    We perform upper endoscopy, when the patient authorizes it, during their screening colonoscopy

Study groups in NCT06316882
Study groupRoleWhat they receive
screening endoscopyWe perform upper endoscopy, when the patient authorizes it, at the same time of their screening colonoscopy
Receives: Diagnostic Test: Screening endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of gastric adenocarcinoma

    number of gastric adenocarcinomas detected in patients undergoing opportunistic endoscopic screening, confirmed by histological examination of biopsies obtained during the screening endoscopic examination

    Measured: 1 month

Secondary outcomes (3)

  1. number of pre-malignant lesions

    number of cases of intestinal metaplasia or atrophic gastritis detected in the histological examination of biopsies obtained during endoscopic screening

    Measured: 1 month

  2. Costs of screening endoscopy

    costs in euros of each endoscopic examination in addition to the base cost of the scheduled colonoscopy screening

    Measured: 1 year

  3. Socio-demographic characteristics of population in screening program

    Determine the correlation between the socio-demographic characteristics of patients and the detection of gastric cancer by opportunistic screening

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start3 Feb 2023
  3. Primary completion24 Feb 2025
  4. Study completion24 Feb 2025

Resources

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
Retrospective
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316882
Sponsor's protocol ID
ROGCAS
Acronym
ROGCAS
Status last verified
Feb 2025
First submitted
21 Nov 2023
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Endoscopic images; endoscopy reports; histopathology reports

Publications

  • Januszewicz W, Turkot MH, Malfertheiner P, Regula J. A Global Perspective on Gastric Cancer Screening: Which Concepts Are Feasible, and When? Cancers (Basel). 2023 Jan 21;15(3):664. doi: 10.3390/cancers15030664.

    PubMed 36765621

  • 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 29511549

  • Faria L, Silva JC, Rodriguez-Carrasco M, Pimentel-Nunes P, Dinis-Ribeiro M, Libanio D. Gastric cancer screening: a systematic review and meta-analysis. Scand J Gastroenterol. 2022 Oct;57(10):1178-1188. doi: 10.1080/00365521.2022.2068966. Epub 2022 May 9.

    PubMed 35531944

  • Kim H, Hwang Y, Sung H, Jang J, Ahn C, Kim SG, Yoo KY, Park SK. Effectiveness of Gastric Cancer Screening on Gastric Cancer Incidence and Mortality in a Community-Based Prospective Cohort. Cancer Res Treat. 2018 Apr;50(2):582-589. doi: 10.4143/crt.2017.048. Epub 2017 Jun 9.

    PubMed 28602053

  • Rawla P, Barsouk A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol. 2019;14(1):26-38. doi: 10.5114/pg.2018.80001. Epub 2018 Nov 28.

    PubMed 30944675

  • Lopez MJ, Carbajal J, Alfaro AL, Saravia LG, Zanabria D, Araujo JM, Quispe L, Zevallos A, Buleje JL, Cho CE, Sarmiento M, Pinto JA, Fajardo W. Characteristics of gastric cancer around the world. Crit Rev Oncol Hematol. 2023 Jan;181:103841. doi: 10.1016/j.critrevonc.2022.103841. Epub 2022 Oct 11.

    PubMed 36240980

  • Kim GH, Liang PS, Bang SJ, Hwang JH. Screening and surveillance for gastric cancer in the United States: Is it needed? Gastrointest Endosc. 2016 Jul;84(1):18-28. doi: 10.1016/j.gie.2016.02.028. Epub 2016 Mar 3.

    PubMed 26940296

  • Lansdorp-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 33975689

  • Almeida N, Romaozinho JM, Donato MM, Luxo C, Cardoso O, Cipriano MA, Marinho C, Fernandes A, Calhau C, Sofia C. Helicobacter pylori antimicrobial resistance rates in the central region of Portugal. Clin Microbiol Infect. 2014 Nov;20(11):1127-33. doi: 10.1111/1469-0691.12701. Epub 2014 Jul 12.

    PubMed 24890952

  • He J, Hu W, Ouyang Q, Zhang S, He L, Chen W, Li X, Hu C. Helicobacter pylori infection induces stem cell-like properties in Correa cascade of gastric cancer. Cancer Lett. 2022 Aug 28;542:215764. doi: 10.1016/j.canlet.2022.215764. Epub 2022 May 31.

    PubMed 35654291

  • Leja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28.

    PubMed 25439074

  • Burra P, Bretthauer M, Buti Ferret M, Dugic A, Fracasso P, Leja M, Matysiak Budnik T, Michl P, Ricciardiello L, Seufferlein T, van Leerdam M, Botos A. Digestive cancer screening across Europe. United European Gastroenterol J. 2022 May;10(4):435-437. doi: 10.1002/ueg2.12230. Epub 2022 Apr 26. No abstract available.

    PubMed 35474447

  • Saftoiu A, Hassan C, Areia M, Bhutani MS, Bisschops R, Bories E, Cazacu IM, Dekker E, Deprez PH, Pereira SP, Senore C, Capocaccia R, Antonelli G, van Hooft J, Messmann H, Siersema PD, Dinis-Ribeiro M, Ponchon T. Role of gastrointestinal endoscopy in the screening of digestive tract cancers in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Apr;52(4):293-304. doi: 10.1055/a-1104-5245. Epub 2020 Feb 12.

    PubMed 32052404

  • Areia M, Carvalho R, Cadime AT, Rocha Goncalves F, Dinis-Ribeiro M. Screening for gastric cancer and surveillance of premalignant lesions: a systematic review of cost-effectiveness studies. Helicobacter. 2013 Oct;18(5):325-37. doi: 10.1111/hel.12050. Epub 2013 Apr 9.

    PubMed 23566268

  • Ishii 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 37731836

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Gastric (Stomach) Cancer, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

number of gastric adenocarcinoma (time frame: 1 month). 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 NCT06316882, which also lists 16 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 27 Feb 2025.

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ROGCAS Clinical Trial NCT06316882 | AzTrials