Implementing Precision Medicine in cOmmunity HospiTALs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 21
- 主要终点
- Proportion of patients for whom ctDNA sequencing
研究概览
简要总结
This is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting
详细描述
Patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy).
All tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. Triple negative breast cancer and Hormone receptor positive, Her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study.
A plasma sample will be collected at baseline and will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if they meet all of the following criteria:
- •Age ≥ 18 years
- •Histology: solid malignant tumor
- •Locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for RH+/HER2- breast cancer: prior treatment with endocrine therapy plus anti-CDK4/6 inhibitor)
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •Measurable disease as per RECIST criteria
- •Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
- •Voluntary signed and dated written informed consent prior to any study specific procedure.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Radiological evidence of symptomatic or progressive brain metastases
- •Previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer
- •Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- •Minors (Age < 18 years)
- •Pregnant or breast-feeding women
- •Previous enrollment in the present study.
研究组 & 干预措施
Biopsy liquid contributive
Patients presenting for whom ct DNA sequencing
干预措施: biopsy liquid (Biological)
结局指标
主要结局
Proportion of patients for whom ctDNA sequencing
时间窗: 72 months
The primary objective of the study will be to evaluate the impact of ctDNA sequencing on the treatment plan of cancer patients managed in satellite centers. This will be performed by estimating the proportion of patients for whom ctDNA sequencing has allowed to propose a systemic treatment that was not considered before the clinician.
次要结局
- Objective Response Rate(72 months)
- Utilization rates of molecular profiling information(72 months)
- Rate of molecular screening failure(72 months)
- Relapsed time between liquid biopsy and matched therapy onset(72 months)
- Rate of patients presenting targetable alterations(72 months)
- Utilization rate of tumor mutational burden(72 months)
- Overall Survival of patients treated with a therapy matched to a targetable alteration and recommended by the MTB based on the ctDNA sequencing(72 months)