Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Efficacy anti-EGFR rechallenge
研究概览
简要总结
This is an observational, retrospective, international and multicenter study funded by Fondazione Oncologia Niguarda ETS to assess the efficacy of anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients screened for RAS/BRAF/PIK3CA ctDNA status on liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The study will collect molecular, clinical and outcome data of patients already available at participating centers.
详细描述
Patient's data to be collected include: age, gender, ethnicity; Eastern Cooperative Oncology Group scale performance status (ECOGPS); date of first diagnosis and date of advanced CRC diagnosis; primary tumor histology; timing of collection of FFPE and liquid biopsy samples; molecular profile data both from archival solid tissue and liquid biopsy; number and sites of metastasis at the time of liquid biopsy draw; medical treatment regimens, lines and locoregional approaches pursued, focusing on the first treatment received by patients following ctDNA analysis; date of death or last follow up. Response evaluation to therapies have to be assessed according to Response Evaluation Criteria in solid tumors (RECIST v1.1) criteria. Information will be provided about resposne to standard treatments (RR and DCR), duration of response (DOR), progression-free survival (PFS), time-to-treatment failure (TTF), OS.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC and screened by ctDNA within the MEN1611-02 clinical trial;
- •Informed consent signature from alive patient;
- •Availability of clinical data detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial;
- •Signed informed consent for molecular screening within the MEN1611-02 clinical trial.
排除标准
- •No data available detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial.
- •Patients enrolled and treated within the MEN1611-02 clinical trial.
研究组 & 干预措施
mCRC patients
Patients diagnosed with mCRC and screened by ctDNA within the MEN1611-02 clinical trial.
结局指标
主要结局
Efficacy anti-EGFR rechallenge
时间窗: Up to two years
The study aims primarily at assessing the efficacy of anti-EGFR rechallenge in the largest real-world cohort of MSS mCRC patients according to RAS/BRAF/PIK3CA ctDNA status taking advantage from the liquid biopsy screening performed as per MEN1611-02 C-PRECISE-01 trial.
次要结局
未报告次要终点