Validation of a Molecular Test for Risk-stratification of Patients With High-risk Intestinal Metaplasia (GCEP2 Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Gastric Cancer
研究概览
简要总结
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.
详细描述
Objectives:
The main objective of this study is to determine whether a customised molecular test can identify prospectively, within patients with intestinal metaplasia (IM), a subgroup of patients with very high risk of dysplasia or gastric cancer (GC). The secondary objectives of this study are to validate the predictive value of a panel of blood microRNA biomarkers for predicting risk of GC, as well as to determine the accuracy of detection of Helicobacter pylori infection using next-generation sequencing, and compare it with the current gold standard, urea breath test.
Study Design:
An international, multicenter cohort to evaluate the clinical utility of a customized molecular test to identify a subset of IM patients at very high risk of GC. Target recruitment is 500 subjects with IM of OLGIM Stage 2 to 4.
As the Updated Sydney biopsy protocol is not routinely performed for clinical purposes and most subjects will be recruited prior to confirming their OLGIM staging at baseline, some subjects will be withdrawn from the study if detected to have no IM, or IM assessed to be OLGIM Stage 1, at baseline OGD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is above 50 years old or turns 50 years old in the year of recruitment
- •The subject is below 76 years old in the year of recruitment
- •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
排除标准
- •The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
- •The subject with a personal history of high-grade dysplasia or GC.
- •The subject with liver cirrhosis.
- •The subject with previous total or partial gastrectomy.
- •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.
- •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.
- •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.
- •The subject is unwilling or unable to provide signed informed consent.
研究组 & 干预措施
Participants with IM of OLGIM Stage 2 to 4
Participants with Intestinal Metaplasia of Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) that is evaluated to be Stage 2 to 4.
干预措施: Blood Collection, processing and analyses (Procedure)
Participants with IM of OLGIM Stage 2 to 4
Participants with Intestinal Metaplasia of Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) that is evaluated to be Stage 2 to 4.
干预措施: Gastroscopy and biopsies collection (Procedure)
Participants with IM of OLGIM Stage 2 to 4
Participants with Intestinal Metaplasia of Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) that is evaluated to be Stage 2 to 4.
干预措施: Urea Breath Test (Diagnostic Test)
结局指标
主要结局
Gastric Cancer
时间窗: 10 years
Number of patients who develop gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma
次要结局
未报告次要终点