Use of Blood Biomarkers to Predict Gastric Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,862
- 试验地点
- 2
- 主要终点
- Gastric cancer
研究概览
简要总结
This study aims to develop a cost-effective screening strategy for the Singapore population by targeted screening of people who have a high risk of stomach cancer, in order to detect early signs of the disease at a stage that can be prevented or cured. Often, patients only consult their doctors when they have advanced symptoms, by which time the cancer may be at a difficult to treat, or incurable stage.
Using costs in the Singapore health system as well as local population risk profiles and demographics, our previous study demonstrated that screening of high-risk groups is cost-effective and a panel of serum makers was effective in differentiating high-risk from low-risk individuals. This study aims to validate the predictive value of various blood biomarkers, such as that of antibodies against Helicobacter pylori, pepsinogen levels, micro RNAs (miRNAs) and blood-based protein markers in participants who have been scheduled to undergo upper gastrointestinal (GI) endoscopy for clinical reasons. If successful, the marker can be used to stratify population into different risk groups and various screening systems can be provided according to different risk level. This will reduce the number of annual invasive screening examinations required to detect early gastric cancer (GC), thereby rendering it cost-effective to generalize as clinical practice in Singapore.
详细描述
Objectives:
This study aims to
- Validate the predictive value of various blood biomarkers, including the panel of antibodies against H.pylori and pepsinogen levels, micro RNAs (miRNAs) and blood-based protein markers in a prospective cohort study involving 8000 participants who have been referred for upper for predicting gastric cancer risk.
- Record the number of participants who are diagnosed with gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma.
- Develop a cost-effective screening strategy based on 1 and 2.
Study Design This is a prospective cohort study involving 8000 subjects who are referred for upper GI endoscopy for standard clinical indications. Blood will be drawn from subjects for blood tests, including antibodies against H. pylori, pepsinogen levels, specific miRNA levels, blood-based protein markers, before undergoing an upper GI endoscopy for clinical reasons. Subjects will be monitored for a period of 10 years via verification with the National Registry of Diseases Office (NRDO) of Singapore. The correlation between the blood test results and findings from the clinical endoscopy or NRDO database verification will be analyzed to determine the predictive value.
Enrolment Patients undergoing upper gastrointestinal endoscopy will be considered for enrolment provided they meet the inclusion and exclusion criteria. 8000 subjects will be enrolled. The Patient Informed Consent Form will be discussed with the patient. If acceptable, the form will be signed by the patient, Principal Investigator and witness if applicable. The subject will be assigned initials and a number in the order in which they were enrolled. Subjects will also be asked to provide information on demographics, family history of gastric cancer, diet, medical history, and lifestyle habits. The data will be captured in a comprehensive database.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is greater than 40 years of age.
- •The subject is scheduled to undergo an endoscopy because of medical indication.
- •The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- •The subject must be willing and able to comply with all study procedures.
排除标准
- •The subject who is unable to undergo gastroscopy.
- •The subject with previous total or partial gastrectomy.
- •The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
- •The subject is unwilling or unable to provide signed informed consent.
- •The subject who is pregnant.
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