Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 22
- 主要终点
- KRAS, NRAS et BRAF mutational status
研究概览
简要总结
RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.
详细描述
The study will be proposed to all patients with a metastatic colorectal cancer.
Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
- •Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
- •Patient information and written informed consent form signed
- •Patient must be affiliated to a social security system
- •Age : 18 years and older
排除标准
- •Patient bearing non-metastatic colorectal cancer
- •Patient with local relapse only
- •Patient with exclusive nodal metastases
- •Patient whose health contraindicates a 30 ml blood sample
- •Blood transfusion within 1 week prior blood collection
- •Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
- •History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
- •Persons deprived of liberty or under supervision
研究组 & 干预措施
OncoBEAM
KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.
干预措施: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA (Genetic)
结局指标
主要结局
KRAS, NRAS et BRAF mutational status
时间窗: up to 6 months
Compare the results of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (V600) genes genotyping using OncoBeam technique in blood samples with results achieved routinely by the molecular genetics platforms of the recruiting centers.
次要结局
未报告次要终点