THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Technical failure rate.
研究概览
简要总结
Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays.
Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing.
Results will be discussed during a molecular screening tumor board.
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
- 否
入选标准
- •Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study.
- •Age ≥ 18 years.
- •Histologically proven metastatic or locally recurrent CRC, NSCLC or melanoma.
- •Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status >
- •The biopsy procedure is estimated to be too risky for the patient.
- •Any anti-VEGF or anti-VEGFR treatment administered less than 3 weeks before new biopsy procedure.
- •No appropriate washout period for patients on anticoagulation therapy.
研究组 & 干预措施
Sequencing of a metastatic lesion.
Biopsy of a metastatic lesion followed by a targeted cancer gene screen.
干预措施: Biopsy of a metastatic lesion. (Procedure)
结局指标
主要结局
Technical failure rate.
时间窗: 1 month
Frequency of failures of each pathological and molecular tests.
Quality of the biopsies
时间窗: 1 month
Percentage of frozen and FFPE core biopsies that are able to provide at least 1.5 μg of DNA of high quality suitable for molecular testing.
Percentage of patients with results within the specified turnaround time
时间窗: 1 month
Percentage of patients for whom biopsy was performed within 10 working days from signature of the ICF and for whom all central laboratory results (pathology and molecular) will be available to the investigator within 15 working days from the time samples are received at the central laboratory (JBI).
次要结局
- Feasibility of a tumor sequencing board.(2 months)