Clinical trial · Observational
Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)
NCT05782465CI-TRIAL-00121058active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is carried out to find out if a customized molecular test can identify a subgroup of patients with very-high-risk of developing stomach cancer within patients with intestinal metaplasia (IM). The investigators hypothesise that the incidence of dysplasia and GC cases in the molecular-test-positive group will be significantly higher than that in the molecular-test-negative group. Such a test has the potential to guide clinicians to better manage patients with IM by allowing endoscopic surveillance to be focused on individuals at very-high-risk of developing stomach cancer, at the same time avoiding or reducing endoscopies for those at lower risk.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Collection, processing and analyses | Procedure | — | UNRESOLVED |
| Gastroscopy and biopsies collection | Procedure | — | UNRESOLVED |
| Urea Breath Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with IM of OLGIM Stage 2 to 4
- description
- Participants with Intestinal Metaplasia of Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) that is evaluated to be Stage 2 to 4.
- interventionNames
- Procedure: Blood Collection, processing and analyses
- Procedure: Gastroscopy and biopsies collection
- Diagnostic Test: Urea Breath Test
Primary outcomes (1)
- measure
- Gastric Cancer
- timeFrame
- 10 years
- description
- Number of patients who develop gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject is above 50 years old or turns 50 years old in the year of recruitment 2. The subject is below 76 years old in the year of recruitment 3. The subject is willing and able to provide signed and dated patient informed consent form indicating that they has been informed of all pertinent aspects of the study Exclusion Criteria: 1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated. 2. The subject with a personal history of high-grade dysplasia or GC. 3. The subject with liver cirrhosis. 4. The subject with previous total or partial gastrectomy. 5. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA), and rheumatoid arthritis (RA) requiring long-term non-steroidal anti-inflammatory drug (NSAID) therapy. 6. The subject with other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgement of the investigator would make the subject unsuitable for entry into the study. 7. The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a 5-day washout period before each gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before each gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety. 8. The subject is unwilling or unable to provide signed informed consent.
References
Publications (10)
- BACKGROUNDde Vries AC, Kuipers EJ. Epidemiology of premalignant gastric lesions: implications for the development of screening and surveillance strategies. Helicobacter. 2007 Nov;12 Suppl 2:22-31. doi: 10.1111/j.1523-5378.2007.00562.x. PMID 17991173
- BACKGROUNDUemura N, Okamoto S, Yamamoto S, Matsumura N, Yamaguchi S, Yamakido M, Taniyama K, Sasaki N, Schlemper RJ. Helicobacter pylori infection and the development of gastric cancer. N Engl J Med. 2001 Sep 13;345(11):784-9. doi: 10.1056/NEJMoa001999. PMID 11556297
- BACKGROUNDYue H, Shan L, Bin L. The significance of OLGA and OLGIM staging systems in the risk assessment of gastric cancer: a systematic review and meta-analysis. Gastric Cancer. 2018 Jul;21(4):579-587. doi: 10.1007/s10120-018-0812-3. Epub 2018 Feb 19. PMID 29460004
- BACKGROUNDHuang KK, Ramnarayanan K, Zhu F, Srivastava S, Xu C, Tan ALK, Lee M, Tay S, Das K, Xing M, Fatehullah A, Alkaff SMF, Lim TKH, Lee J, Ho KY, Rozen SG, Teh BT, Barker N, Chia CK, Khor C, Ooi CJ, Fock KM, So J, Lim WC, Ling KL, Ang TL, Wong A, Rao J, Rajnakova A, Lim LG, Yap WM, Teh M, Yeoh KG, Tan P. Genomic and Epigenomic Profiling of High-Risk Intestinal Metaplasia Reveals Molecular Determinants of Progression to Gastric Cancer. Cancer Cell. 2018 Jan 8;33(1):137-150.e5. doi: 10.1016/j.ccell.2017.11.018. Epub 2017 Dec 28. PMID 29290541
- BACKGROUNDDixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol. 1996 Oct;20(10):1161-81. doi: 10.1097/00000478-199610000-00001. PMID 8827022
- BACKGROUNDNoguchi M. Racial factors cannot explain superior Japanese outcomes in stomach cancer. Arch Surg. 1997 Jan;132(1):99. doi: 10.1001/archsurg.1997.01430250101021. No abstract available. PMID 9006560
- Filipe MI, Munoz N, Matko I, Kato I, Pompe-Kirn V, Jutersek A, Teuchmann S, Benz M, Prijon T. Intestinal metaplasia types and the risk of gastric cancer: a cohort study in Slovenia. Int J Cancer. 1994 May 1;57(3):324-9. doi: 10.1002/ijc.2910570306.