Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Colorectal cancer
研究概览
简要总结
CoLiQ is a clinical study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling.
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
- •Patient ≥ 18 years old summoned for colonoscopy
- •Patient able to understand and sign written informed consent
排除标准
- •Patient < 18 years old
- •Patient unable to understand or give written informed consent
- •Patient unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator as unlikely to complete the study
结局指标
主要结局
Colorectal cancer
时间窗: evaluated within 3 months after colonoscopy
Number of patients with colorectal cancer at histology following colonoscopy
Colorectal adenoma
时间窗: evaluated within 3 months after colonoscopy
Number of patients with colorectal adenoma at histology following colonoscopy
Inflammatory bowel disease
时间窗: evaluated within 3 months after colonoscopy
Number of patients with inflammatory bowel disease at histology following colonoscopy
次要结局
- Treatment response(Within the 5 years following diagnosis of colorectal cancer)
- Recurrence(Within 5 years following treatment with curative intent for colorectal cancer)
- Death(Within 5 years following diagnosis of colorectal cancer)