Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,057
- 试验地点
- 1
- 主要终点
- Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers
研究概览
简要总结
This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).
Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers.
Secondary objectives:
- To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests.
- To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.
详细描述
This is a multi-centre, prospective cohort study recruiting participants aged 40 or above, who present at the Outpatient Clinic of the study hospitals either for periodically follow-up visits for their chronic conditions, or for annually health check-up. The study will be conducted at the Medical Genetic Institute, in collaboration with the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam and other collaborating hospitals.
The potential participants, who satisfy all inclusion/exclusion criteria will be recruited into this study. These potential participants should not have history of cancer before being enrolled in the study.
At enrolment, each participant will answer to a pre-designed questionnaire to provide demographic information, past major medical history and clinical warning signs of cancers, and then provide 10mL of blood for analysing the circulating tumour DNA (ctDNA).
Each participant will get either ctDNA detected or ctDNA not detected.
For those having ctDNA detected in their blood, they will then undergo the screening and diagnostic tests for cancers based on the prediction of tumour origin provided in the test findings report. If the cancers lab-confirmed, patients will then be followed up and managed for their disease according to the guidelines of the Vietnam Ministry of Health and/or the international guidelines on cancers. At 12 months (+/- 1 week) following the enrolment, these patients will be contacted to collect information about their health, in general and their cancer status, in particular.
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
- •Aged 40 or above at enrolment
- •Neither clinical suspicion of cancer nor history of confirmed cancer has been reported
- •Agree to be contacted at 6 months and 12 months following enrolment to collect information about general health status and progress of cancer (if possible)
- •Provide written informed consent
排除标准
- •If a potential participant has any one of the following criteria, he/she will not be able to be enrolled in the study:
- •History of cancer (cancer has either been confirmed or been treated within the past 3 years)
- •History of blood transfusion or bone marrow transplantation within the past 3 years
- •Does not agree to participate in study
- •The subject has clinical manifestations of pregnant.
结局指标
主要结局
Positive predictive value, Negative predictive value of the blood ctDNA test in early detecting cancers
时间窗: 12 months following enrolment
Sensitivity and specificity of the test in early detecting cancers
时间窗: 12 months following enrolment
次要结局
- Rate of cancer development in the high-risk group as compared to the moderate-risk population(12 months following enrolment)
- Positive predictive value of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests(12 months following enrolment)