ctDNA-FGFR Status as a Predictive Biomarker for FGFR Targeted Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
- 试验地点
- 7
- 主要终点
- To evaluate the diagnostic value of ctDNA testing against standard tissue testing
研究概览
简要总结
A new drug, erdafitinib, became available for some patients with bladder cancer that has spread to other organs. To qualify, patients must have specific genetic changes in their tumors. Currently, doctors use tumor tissue samples to check for these genetic changes, but these samples might not accurately reflect the current state of the patient's cancer.
In this study, Investigators will test the patient's blood for these genetic changes in addition to the tumor tissue samples. It is thought that the blood test will give a more accurate result.
Investigators hope this study will help to find out if more patients can benefit from erdafitinib than the ones identified by tissue testing only.
详细描述
Recently, the first targeted therapy for patients with metastatic urothelial cancer (mUC) received approval, i.e. erdafitinib. Erdafitinib is a pan-FGFR small molecule inhibitor. Approximately twenty percent of mUC patients' tumors harbor qualifying alterations in FGFR2 or FGFR3. Currently, standard testing uses archival tumor tissue. However, this type of testing may not be representative of a patient's clinically dominant tumor clone at the time of treatment initiation due to temporal and spatial biopsy bias of archival tissue testing.
In this study, patients will undergo circulating tumor DNA testing, in addition to conventional tissue testing, for treatment eligibility. Investigators hypothesize that blood-based ctDNA testing will provide a more accurate assessment of somatic FGFR status than same patient archival primary tissue.
This study's objectives are:
Objective 1 (Primary): To evaluate the diagnostic value of ctDNA testing against the "gold standard" of tissue testing.
Objective 2 (Secondary): To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR alterations that are currently missed on tissue assays.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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 with metastatic bladder cancer who are about to undergo tissue testing for FGFR mutations and who have blood samples drawn during the management of their disease are eligible to be included in this analysis.
排除标准
- •Metastatic bladder cancer patients who will not have tissue sent for FGFR testing will be excluded from this study.
结局指标
主要结局
To evaluate the diagnostic value of ctDNA testing against standard tissue testing
时间窗: For the primary objective, a single blood sample is collected at the time of screening for treatment eligibility
Investigators will evaluate ctDNA as a diagnostic test against the de facto gold standard of tissue testing.
次要结局
- To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR mutations that are currently missed on tissue assays(For this secondary objective, a single blood sample is collected at the time of screening for treatment eligibility)
研究者
Bernie Eigl
Principal Investigator
British Columbia Cancer Agency