Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 6
- 主要终点
- Sensitivity and specificity of the screening test with comparison to colonoscopy
研究概览
简要总结
The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally.
详细描述
This multicenter research intends to enroll 3,600 participants according to predefined inclusion and exclusion criteria. The study will be divided into two groups: the "cancer arm" and the "control arm", with the "control arm" further subdivided into the "general-risk arm" and the "high-risk arm". All participants enrolled in this study will be required to provide a 10 ml whole blood sample.
This study consists of two sections. The first section involves constructing an diagnostic prediction model for early CRC detection, and the second section focuses on validating and optimizing this prediction model.
In the first section, a prediction model for the early detection of CRC will be developed with a cohort of 1,700 participants. This cohort comprises 900 individuals in the cancer arm, including 800 CRC patients and 100 with advanced adenoma (AA), along with 800 individuals in the control rm. All participants will be required to provide a 10 ml blood sample. Cell-free DNA (cfDNA) and microRNA (miRNA) will be sequenced and analyzed with the next-generation sequencing (NGS) platform,. And cancer specific markers will be identified to construct an early detection liquid biopsy prediction model by leveraging machine learning techniques and incorporating clinical pathological diagnostic information.
In the second section, a total of 1,900 participants were include, with 1,100 in the "cancer arm" (800 CRC and 300 AA patients) and 800 in the "control arm", the prediction model established in the first section will be validated in an external cohort, and algorithm optimization will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- •History of other malignant tumors (excluding non-melanoma skin cancer).
- •Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).
- •Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).
- •Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.
- •Prior blood transfusion (including blood components) within the past 2 weeks.
- •Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.
- •Pregnancy women.
- •Prior or current anti-infection treatment within 14 days before blood collection.
- •Inability to comply with study procedures such as blood collection and related examinations.
- •Deemed unsuitable for participation in the clinical trial by the investigator.
结局指标
主要结局
Sensitivity and specificity of the screening test with comparison to colonoscopy
时间窗: Through study completion, an average of 3 year
Cancer specific markers will be identified to construct an early detection liquid biopsy prediction model, which will be compared with diagnostic colonoscopy.
次要结局
未报告次要终点
研究者
Ding Ke-Feng
Chief physician
Second Affiliated Hospital, School of Medicine, Zhejiang University