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

NCT06316882 | Completed DMC

• 1 other identifier: ROGCAS
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic screening of gastric cancer combined with screening colonoscopy

Conditions

Gastric Cancer; Gastric (Stomach) Cancer; Atrophic Gastritis; Intestinal Metaplasia of Gastric Mucosa; HELICOBACTER PYLORI INFECTIONS; High Grade Intraepithelial Neoplasia

Keywords

Gastric Cancer; Endoscopic screening; intermediated risk countries

Outcome Measures

Primary Outcomes (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

  1 month

Secondary Outcomes (3)

• number of pre-malignant lesions

  1 month

• Costs of screening endoscopy

  1 year

• Socio-demographic characteristics of population in screening program

  1 month

Study Arms (1)

screening endoscopy

We perform upper endoscopy, when the patient authorizes it, at the same time of their screening colonoscopy

Diagnostic Test: Screening endoscopy

Interventions

Screening endoscopy DIAGNOSTIC_TEST

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

Also known as: upper endoscopy

screening endoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Exams without biopsies

Sponsors & Collaborators

• Unidade Local De Saúde Do Norte Alentejano: lead
• NOVA Medical School: collaborator
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

ULSNA

Portalegre, Portalegre District, 7300-853, Portugal

Location

Related Publications (16)

• 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.

  PMID: 36765621 BACKGROUND

• 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.

  PMID: 29511549 BACKGROUND

• 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.

  PMID: 35531944 BACKGROUND

• 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.

  PMID: 28602053 BACKGROUND

• 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.

  PMID: 30944675 BACKGROUND

• 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.

  PMID: 36240980 BACKGROUND

• 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.

  PMID: 26940296 BACKGROUND

• 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.

  PMID: 33975689 BACKGROUND

• 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.

  PMID: 24890952 BACKGROUND

• 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.

  PMID: 35654291 BACKGROUND

• 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.

  PMID: 25439074 BACKGROUND

• 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.

  PMID: 35474447 BACKGROUND

• 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.

  PMID: 32052404 BACKGROUND

• 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.

  PMID: 23566268 BACKGROUND

• 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.

  PMID: 37731836 BACKGROUND

• Mourato 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.

  PMID: 40762368 DERIVED

Related Links

• Global Cancer Observatory
• National Cancer Institute

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: March 19, 2024
• Study Start: February 3, 2023
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: end of study
• Access Criteria: investigators of other clinical trials and systematic reviews

Locations

PT (1)