Targeted Genomic Analysis of Human Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 20
- 主要终点
- Rate of actionable mutations in rare and/or poor prognosis cancers
研究概览
简要总结
This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.
详细描述
PRIMARY OBJECTIVES:
I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.
II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed.
III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data.
IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky/Lansky performance score >= 30
- •A signed written informed consent
- •Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment
- •Paraffin blocks of the patient's tumor tissue are available and accessible for analysis
排除标准
- •Karnofsky/Lansky performance score < 30
- •Life expectancy < 3 months
研究组 & 干预措施
Ancillary-Correlative (genomic analysis)
Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free DNA and circulating tumor cells.
干预措施: Cytology Specimen Collection Procedure (Other)
Ancillary-Correlative (genomic analysis)
Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free DNA and circulating tumor cells.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Rate of actionable mutations in rare and/or poor prognosis cancers
时间窗: Up to 15 years
The actual rate of mutations found in this study will be determined to estimate the true underlying mutation rate.
Frequencies of individual specific mutations and combinations of mutations of related pathway genes
时间窗: Up to 15 years
Descriptive analysis will be used to determine frequencies of specific mutations and to determine the pathways that can be targeted most frequently in patients with rare/poor prognosis cancer.
次要结局
未报告次要终点
研究者
Frances Di Clemente
Program Manager
Rutgers, The State University of New Jersey