ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- 5y DFS
研究概览
简要总结
In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.
详细描述
This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.
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
- •Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer.
- •Male or female ≥ 18 years of age on the day of signing informed consent.
- •Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC).
- •Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
排除标准
- •Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
- •Induction of neoadjuvant systemic therapy prior to resection of CRC.
- •Patient is pregnant or lactating.
- •Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
- •Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
结局指标
主要结局
5y DFS
时间窗: 5 years
The 5-year disease free survival rate of the patients from both cohorts.
ctDNA methylation markers versus CT/MRI
时间窗: 5 years
ctDNA methylation predictors of outcome will be compared to CT/MRI
次要结局
- 3y DFS(3 years)