Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Thoroughness to report molecular profiling
研究概览
简要总结
The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.
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
- •Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
- •Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital.
- •Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year.
- •ECOG PS 0-
- •No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
- •Signed informed consent.
排除标准
- •Symptomatic brain metastases.
- •Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption.
- •History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years.
- •No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
结局指标
主要结局
Thoroughness to report molecular profiling
时间窗: 14 days from sample acquisition
Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition.
次要结局
- Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC(24 months from first patient in.)
- Percentage of complete data capture for treatment-related check-point events(through study completion, an average of five years)