Predicting the Efficacy and Prognosis of Rectal Cancer Patients Receiving Neoadjuvant Chemoradiotherapy Based on Circulating Tumor DNA-minimal Residual Disease Technology : A Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Area under the ROC curve (AUC) of the MRD biomarker
研究概览
简要总结
The purpose of this study is to study the performance of MRD monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore the value of MRD detection in evaluating the prognosis of patients. In this prospective study, 50 patients with stage II-III rectal cancer who are planing to receive neoadjuvant chemoradiotherapy will be enrolled. The tumor tissue will be collected by colonoscopy before treatment and blood samples will be collected before treatment and during treatment.The whole blood samples will receive MRD detection. The change rate and clearance rate of MRD during treatment will be calculated, and will be associated with imaging efficacy evaluation, pathological efficacy evaluation,and prognosis, to determine the performance of MRD in predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative recurrence of rectal cancer.
详细描述
This study is a prospective, observational study. It is expected to enroll 50 patients with newly diagnosed stage II-III rectal cancer.Before neoadjuvant chemoradiotherapy, tumor tissue will be collected by colonoscopy biopsy for WES and customized panel design, and peripheral blood samples will be collected for baseline MRD detection ( MRD1 ) and during neoadjuvant concurrent chemoradiotherapy ( MRD2-6 ) .Peripheral blood sample will be collected 3-4 weeks after radical surgery ( MRD7 ). For patients who achieved cCR after the end of neoadjuvant therapy and adopted the W & W ( watch and wait ) strategy, the sampling time point was 3 months after the start of watching and waiting ( MRD7 ).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal adenocarcinoma confirmed by pathology
- •The clinical stage is II-III.
- •Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose to wait for observation ).
- •No distant metastasis ;
- •Main organ function is normal ;
- •signed informed consent and willing to accept long-term follow-up；
- •No anti-tumor treatment was received within 4 weeks before baseline sampling ;
- •Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization, and sufficient whole blood samples need to be provided for baseline MRD detection.
排除标准
- •unable to provide sufficient tissue / blood samples to meet the research needs ;
- •received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ;
- •Patients did not receive neoadjuvant therapy according to the original plan ;
- •Patients refused to accept genetic testing. -
结局指标
主要结局
Area under the ROC curve (AUC) of the MRD biomarker
时间窗: Baseline to 12 months
The area under the ROC curve ( AUC ) of MRD
次要结局
- Distant metastases-free survival（DMFS）(From date of the beginning of neoadjuvant chemoradiotherapy to disease metastasis or death due to any cause,assessed up to 60 months.)
- Local recurrence-free survival（LRFS）(From date of radical surgery to local recurrence or death due to disease progression，assessed up to 60 months.)
研究者
WeiWei Xiao
Sun Yat-sen University
Sun Yat-sen University