Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
研究概览
简要总结
Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so.
详细描述
The purpose of this study is to assess whether a new ctDNA assay developed by Foundation Medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the FoundationOne® test. Study sites will provide matched solid tumor and peripheral blood samples of cancer patients to FMI for the purpose of testing the concordance of the FMI ctDNA assay to the FoundationOne® test. Participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctDNA profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctDNA from their blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care
排除标准
- •Tumor specimens where no cancer representative of the diagnosis is found in submitted tissue
- •Tumor specimens where insufficient DNA (<50 ng) is provided to run the FoundationOne test.
- •Tumor specimens with ≤20% tumor nuclei (all specimens).
结局指标
主要结局
Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
时间窗: 6-12 months
Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples
时间窗: 6-12 months
次要结局
未报告次要终点