NCT02342158已完成不适用
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2014年11月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
研究概览
简要总结
PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.
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
- •Age>18 years
- •Histological diagnosis of cancer
- •Locally advanced or metastatic, biopsiable disease
- •ECOG Performans Status ≤2
- •Affiliation to social security
- •Signed informed consent.
排除标准
- •Emergency, Individually deprived of liberty or placed under the authority of a tutor
- •Patients with symptomatic or progressive brain metastasis
- •Patients who have only bone and/or brain metastases
- •Pregnant or breastfeeding women
研究组 & 干预措施
Locally advanced /metastatic cancer
Experimental
干预措施: biopsy or surgical sampling (Procedure)
Locally advanced /metastatic cancer
Experimental
干预措施: blood sampling (Other)
结局指标
主要结局
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
时间窗: 4-6 weeks after biopsy
次要结局
- Circulating tumor DNA detection and characterization in locally advanced and metastatic disease(4 years)
- Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing(3.5 years)
- Full exome and transcriptome sequencingof locally advanced and metastatic tumours(6 years)
- Circulating Tumor Cells (CTC) detection and characterization in breast cancer(3.5 years)
- Preclinical predictive clinical models validation (limited to breast cancer)(4 years)
研究者
研究点 (2)
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