NCT02112357Unknown不适用
FOrMAT - Feasibility of a Molecular Characterisation Approach to Treatment
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.
研究概览
简要总结
This study will assess the feasibility of sequencing locally advanced/metastatic gastrointestinal cancers in real-time to enable future treatment stratification by molecular characteristics. Targeted next generation sequencing of a panel of genes will be performed on tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a patient is potentially suitable for a targeted therapy.
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
- •Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).
- •Histological or cytological confirmation of diagnosis of malignancy.
- •Patients must either:
- •Have received at least one line of treatment for locally advanced/metastatic disease OR
- •Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease
- •18 years of age and over .
- •Performance status less than or equal to
- •Able to provide fully informed consent.
- •Patients must either:
- •Have an available tumour specimen (FFPE or fresh frozen) from either the primary tumour or a metastasis. Metastatic samples may be from any site with the exception of bone. OR
- •Have a site of disease which is amendable to biopsy
排除标准
- •There are no specific exclusion criteria for this study.
结局指标
主要结局
The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.
时间窗: 18 months
次要结局
- The proportion of patients in whom genetic sequencing was successfully performed.(18 months)
- The concordance of results obtained from core biopsy versus fine needle aspirate specimens from individual patients.(18 months)
- The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate.(18 months)
- The percentage of patients with a currently actionable genetic alteration who received targeted therapy as a result of genetic sequencing.(18 months)
- The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.(18 months)
- Evaluation of the time required to obtain genetic sequencing results to see if genetic sequencing could be practically incorporated into clinical practice.(18 months)
- The number needed to enroll into the trial to identify one patient with a targetable genetic alteration and the number needed to enroll into the trial to treat one patient with a targeted agent.(18 months)
研究者
研究点 (1)
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