Genomic Profiling Assay in Phase I
A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population
研究概览
详细说明
If you agree to take part in this study, your tumor tissue collected previously from surgery or a prior biopsy (archived tissue) will be used for genetic testing. Genetic testing looks at whether specific genes are changed (mutated) in the tumor.
The results of the genetic testing will be documented in your medical record. Your doctor may use the results of the genetic testing to help decide which treatment you will have. While awaiting results of the genomic profile assay, you may be enrolled in another treatment either at MD Anderson or near your home. This will be decided by your treating physician.
Your samples will be given a code number when they are sent for genetic testing to Foundation Medicine. No identifying information will be directly linked to your samples. Only the researcher in charge of sending all tissue for testing will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Foundation Medicine will not be able to link this data to you.
Researchers will also review your medical history from before and following the collection of tissue, to learn if the use of genetic testing had any effect on the outcome of your treatment.
This is an investigational study.
Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria
- Patients with advanced cancer.
- Consent for use of archival tissue from primary or metastatic cancer diagnosis. Note: Patients may currently be enrolled in other investigational protocol including treatment protocols.
- Control Group #2 only: Control Group #2 will consist of 100 patients from MDACC/Phase I historical archives. Patients (cases no older than 2 years) will be selected based on clinical characteristics and genomic alterations similar to matched targeted therapy group.
- Patients may have received prior 'matched' therapies; however, at the time of enrollment, patients may not currently be on a known 'matched' therapy, and may not have received a 'matched' therapy as the last treatment if not receiving treatment at the time of consent.
- Patients who have a life expectancy of greater than 3 months.
Exclusion Criteria:
- Patients with advanced cancer who are NOT likely to meet the additional enrollment criteria in matched targeted therapy protocols or treatments.
- Patients who do not have archival tissue available.
- Patients are excluded if their last treatment before enrollment included a targeted agent matched to a genomic alteration in the patient's tumor.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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Control Group #1
Participants who have had tumor molecular analysis performed with the similar clinical characteristics and genomic aberrations but who receive therapy not matched to their aberrations, or who have received results from Foundation Medicine that fail to demonstrate any molecular alteration.
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Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.
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Control Group #2
Participants from historical archives of MD Anderson, no older than two years, who received therapy not matched to their aberrations and are matched not only on the basis of the clinical characteristics, but also, as much as possible, on the basis of genomic aberrations.
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Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.
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Matched Targeted Therapy Group
Participants with tumor aberrations who received matched targeted therapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Response Rate
大体时间：6 months
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Response rate of each of the three cohorts (matched targeted therapy group, control group #1 and control group #2) calculated along with its 95% confidence interval.
Response rate defined as proportion of participants who experience complete response (CR) or partial response (PR).
Clinical response evaluated according to the RECIST 1.1.
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6 months
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合作者和调查者
调查人员
- 学习椅：Funda Meric-Bernstam, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PA12-0360
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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