A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
研究概览
简要总结
This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.
The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.
详细描述
AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.
The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.
The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 19 years or older
- •Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination
- •Subjects who have agreed to provide clinical information and blood samples
- •Subjects who have agreed for the storage and secondary use of residual blood samples for research
- •Subjects who have understood the study and are able to provide a written informed consent
排除标准
- •Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders
- •Subjects with a history of HIV, HTLV, or Syphilis infection
- •Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers
- •Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)
结局指标
主要结局
Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
时间窗: 36 months
Accuracy of prediction for the origin of cancer, assessed by concordance rate
时间窗: 36 months
次要结局
未报告次要终点