Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 506
- 试验地点
- 19
- 主要终点
- Percentage of patients with one or more genetic abnormalities among all examination cases
研究概览
简要总结
This study is a genetic analysis of aberrations in circulating tumor DNA (ctDNA) in patients in Asian countries. This study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.
详细描述
NGS analysis will be performed on cfDNA extracted from peripheral blood samples of target patients to determine the types and incidences of genetic abnormalities. Patient information and gene abnormality data will be integrated, and the types and incidences of gene abnormalities by cancer type will be analyzed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older at registration.
- •Diagnosis of cancer which is targeted by each cohort.
- •Metastatic and/or recurrent disease.
排除标准
- •Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix.
- •Ongoing chemotherapy. (Chemotherapy-naïve patients or awaiting initiation of the next line of chemotherapy are eligible. There is no limit on the number of prior chemotherapies or on the time from completion of chemotherapy to registration).
- •Ongoing radiation therapy. (There are no limits on the time from completion of radiation therapy to registration).
结局指标
主要结局
Percentage of patients with one or more genetic abnormalities among all examination cases
时间窗: Through study completion, an average of 1 year
DNA may be extracted from blood or tumor tissue samples, and germline gene abnormality may be analyzed using techniques such as PCR, NGS, and Sanger sequencing.
Percentage of patients with each genetic abnormality among all examination cases
时间窗: Through study completion, an average of 1 year
DNA may be extracted from blood or tumor tissue samples, and germline gene abnormality may be analyzed using techniques such as PCR, NGS, and Sanger sequencing.
次要结局
- Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate(Through study completion, an average of 1 year)