Decision Impact Analysis of Foundation Medicine's Next Generation Sequencing Test in Advanced Solid Tumor Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Feasibility of NGS on metastatic solid tumor tissue, in terms of number of patients screened, FMI test attempted, FMI test successful, and FMI tests results released to physicians
研究概览
简要总结
This pilot clinical trial studies comprehensive gene sequencing in guiding treatment recommendations in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan treatment.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility and logistics associated with a clinical trial utilizing the Foundation Medicine Incorporated (FMI) test in an academic therapeutic setting.
II. To determine the proportion of patients who will receive a cancer-related therapy based on the results provided by the FMI test.
SECONDARY OBJECTIVES:
I. To explore and report estimates of progression free survival (PFS) of the regimen administered after the FMI test results are revealed and the PFS of the most recent regimen administered before the FMI test results were received.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Are able to understand and provide written informed consent (most recent patient informed consent form) prior to initiation of any study-specific procedures
- •Patients are diagnosed with recurrent or metastatic a solid tumor cancer; the first patients to be enrolled will have a diagnosis of breast cancer (Cohort 1) or colorectal cancer (Cohort 2)
- •Patients may enter this study at any line of therapy
- •Patients must have a tumor sample available for NGS testing
- •Patients are within 10 weeks of starting their current line of therapy and enrolled before their 1st computed tomography (CT) scan
- •Have an expected survival of >= 3 months, as estimated by the treating oncologist
- •Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2
排除标准
- •Are pregnant or nursing women
- •Are unable to comply with requirements of the study
- •Have a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
结局指标
主要结局
Feasibility of NGS on metastatic solid tumor tissue, in terms of number of patients screened, FMI test attempted, FMI test successful, and FMI tests results released to physicians
时间窗: Up to 18 months
Summary tables will be generated.
Feasibility of NGS result-based non-FDA-approved treatment plan, measured by reasons for ability or inability to receive an anti-cancer agent
时间窗: Up to 18 months
Summary tables will be generated.
Availability of recommended experimental regimens via clinical trials
时间窗: Up to 18 months
Proportion of patients who have one recommended therapy
时间窗: Up to 18 months
The proportion of patients who have one recommended therapy recommended will be assessed and compared with the proportion who have multiple options recommended. Summarized, and estimates derived along with corresponding 95% confidence intervals.
Proportion of patients who have multiple options recommended
时间窗: Up to 18 months
The proportion of patients who have one recommended therapy recommended will be assessed and compared with the proportion who have multiple options recommended. Summarized, and estimates derived along with corresponding 95% confidence intervals.
次要结局
- Presence of any oncogene or tumor suppressor gene mutations or amplifications identified by NGS on tumor tissue in each cohort(Up to 18 months)