Investigation of the Value of ctDNA Analysis in the Diagnosis, Treatment, and Surveillance of Patients With Surgically Resectable Colorectal Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 主要终点
- 5y LR
研究概览
简要总结
In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical specimens, and observation of patients undergoing radical resection of the tumor with or without adjuvant chemo- and/or radiotherapy.
详细描述
A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of the combined modality treatment for colorectal cancer and the patients' long-term prognosis.
Research objects: patients with surgically resectable colorectal cancer. After giving fully informed consent, the prospective participants will undergo the classical combined modality treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, (post-NCRT for NCRT patients), postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The 3 year disease free survival (3y-DFS) will be the primary end-point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 75 years old.
- •Patients with surgically resectable colorectal cancer, while without distal metastasis of the disease.
- •Patients with ASA physical status scroe of I to III.
- •Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.
- •Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.
排除标准
- •Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).
- •Patient is pregnant or lactating.
- •Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.
- •Patient is participating in any other clinical trials within 30 days prior to screening.
- •Patient has severe mental illness.
- •Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.
研究组 & 干预措施
ACT group
Group of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin.
干预措施: Capecitabine +/- Oxaliplatin (Drug)
Non-ACT group
Group of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy.
干预措施: No adjuvant chemotherapy (Other)
LR group
Group of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR)
干预措施: local resection (Procedure)
RR group
Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR)
干预措施: radical resection (Procedure)
结局指标
主要结局
5y LR
时间窗: 5 years
The 5-year local recurrence rate of the patients.
5y DFS
时间窗: 5 years
The 5-year disease free survival rate of the patients.
5y OS
时间窗: 5 years
The 5-year overall survival rate of the patients.
次要结局
- Changes of ctDNA level after surgery(1 month)
- Changes of ctDNA level when disease recurs(5 year)
- Changes of ctDNA level after adjuvant therapy(6 months)
研究者
Guole Lin
Professor
Peking Union Medical College Hospital