Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer treatment that aims to more precisely identify and attack cancer cells, in an effort to do less damage to normal cells.
详细描述
Targeted therapy in this study can be either off label-use of a U.S. Food and Drug Administration (FDA) approved drug or a clinical trial that includes investigational drugs. Matched targeted therapy outcomes will be compared to the outcomes of patients who were not matched to a treatment.
In order to find a matched treatment, a patient's sample will undergo a test known as a "gene chip algorithm." This is will be done by having a sample of a patient's tumor analyzed at a Cedars-Sinai Medical Center (CSMC) laboratory that specializes in molecular profiling. Molecular profiling is a process used to study a tumor's genetic characteristics. DNA will be taken from the tumor sample and will be screened for "actionable genes." These genes are called actionable because mutations (structural changes) in these genes have FDA-approved matched therapies or are eligible for current clinical studies.
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
- •Advanced and metastatic solid tumors who have failed standard treatments known to improve survival
- •Female and male adults age 18 and older.
- •ECOG PS 0-2
- •Acceptable hematological, renal, or liver function
- •Patients planning to undergo a systemic treatment
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Significant comorbidities that could interfere with the study (compliance and visits)
结局指标
主要结局
Response rate
时间窗: 3 years
To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.
次要结局
- Overall survival(3 years)
- Progression free survival(6 months)
研究者
Monica Mita
Associate Professor of Medicine
Cedars-Sinai Medical Center