NCT04339933尚未招募不适用
Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
Ho Kyung Seo0 个研究点目标入组 92 人开始时间: 2022年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 主要终点
- Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment
研究概览
简要总结
This study aims to compare the correlation between FGFR mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of FGFR inhibitors using urine samples of the patients with urothelial cancer.
详细描述
This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.
■ Examination Methods
- FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
- FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
- Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
- Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected patients of urothelial cancer who will visit the National Cancer Center Korea from the date of Institutional Review Board (IRB) approval to 2021 and with identified tumors in the bladder according to bladder endoscopy.
- •Subjects who are scheduled for surgery (transurethral bladder tumor resection, radical bladder resection, and radical bladder ureterectomy) and have agreed to participate in the study
排除标准
- •History of other active malignant tumors treated within 24 months
- •Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors
- •If patients and guardians do not want to participate in this study
- •History of having administered FGFR inhibitors in the past
结局指标
主要结局
Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment
时间窗: Up to two weeks before and after surgery
The ratio of patients with matching test results to total patients
次要结局
- PD-L1 expression(Up to two weeks before and after treatment)
- Patient prognosis(six months and one year after treatment)
- Changes in FGFR mutations in tissues before and after treatment(Up to two weeks before and after treatment)
研究者
Ho Kyung Seo
Senior Scientist
National Cancer Center, Korea
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