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NCT05782465 · ClinicalTrials.gov registry record
Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)
A clinical trial of Stomach Neoplasm, sponsored by National University Hospital, Singapore.
- Active
- Registry status
- 500
- Enrollment target
- 8
- Study locations
NCT05782465: Active study of Stomach Neoplasm, sponsored by National University Hospital, Singapore.
NCT05782465 is a study of Stomach Neoplasm that is active but no longer recruiting, run by National University Hospital, Singapore. The registered enrollment target is 500 participants. The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05782465, a study of Stomach Neoplasm, is active but no longer recruiting, sponsored by National University Hospital, Singapore.
- ACTIVE NOT RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
Number of patients who develop gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma
Conditions Studied
Interventions
- PROCEDURE Blood Collection, processing and analyses
- PROCEDURE Gastroscopy and biopsies collection
- DIAGNOSTIC_TEST Urea Breath Test
Study Locations (8)
Other
- The Chinese University of Hong Kong - Hong Kong
- Nihon University School of Medicine - Tokyo
- National University Hospital - Singapore
- Yonsei University, Republic of Korea - Seoul
- National Taiwan University Hospital - Taipei
Singapore
- Singapore General Hospital - Singapore
- Tan Tock Seng Hospital, Singapore - Singapore
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2019-08-23 |
| Est. Completion | 2033-12 |
What the registry record for NCT05782465 still lists
NCT05782465 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Stomach Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Blood Collection, processing and analyses is the first listed.
NCT05782465 lists 8 locations in 3 states (Other, Singapore, California).
Frequently Asked Questions
What is clinical trial NCT05782465 about?
NCT05782465 is a clinical study titled "Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)". 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-...
What is the current status of trial NCT05782465?
This trial is currently active not recruiting. The enrollment target is 500 participants. The study started on 2019-08-23. Estimated completion is 2033-12.
What conditions does trial NCT05782465 study?
This clinical trial studies the following conditions: Stomach Neoplasm.
What interventions are being tested in trial NCT05782465?
The interventions under investigation include: Blood Collection, processing and analyses (PROCEDURE), Gastroscopy and biopsies collection (PROCEDURE), Urea Breath Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05782465?
This trial is sponsored by National University Hospital, Singapore, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05782465 being conducted?
This trial has 8 study locations across California, Singapore. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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