Feasibility Study of Circulating Tumour DNA Analysis in Urine (Urinary cfDNA) as a Non-invasive Monitoring Tool in Patients With Prostate or Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- concentration of cfDNA obtained in urine
研究概览
简要总结
The UroDNA study is a feasibility study (RIPH category 3) aimed at evaluating the analysis of circulating tumour DNA in urine (urinary cfDNA) as a non-invasive monitoring tool in patients with prostate or bladder cancer. Urine samples will be collected at different times during the course of treatment to define the optimal conditions for cfDNA collection, extraction and analysis, and to explore the detection of tumour mutation profiles. This study does not involve any experimental treatment. Its objective is to validate the technical and clinical feasibility of a molecular monitoring urine test, which could offer a simple and non-invasive alternative to improve the management of urological cancers.
详细描述
Patients will be included as they are admitted to the facility. If they agree to participate, two urine samples will be collected at the start of treatment and at the end of the treatment sequence.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Five patients for each of the following cancers :
- •Patients with high-risk localised prostate cancer eligible for high-dose radiotherapy, or
- •Patients with mHSPC eligible for docetaxel chemotherapy, or
- •Patients with mCRPC in second-line treatment eligible for luPSMA treatment, or
- •Patients with localised bladder cancer eligible for neoadjuvant chemotherapy or,
- •Patients with metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)
排除标准
- •History of cancer in the 5 years prior to entering the trial other than basal cell skin cancer or cervical carcinoma in situ,
- •Women who are pregnant, likely to become pregnant or breastfeeding,
- •Persons deprived of their liberty, under judicial protection, under guardianship or placed under the authority of a guardian, Inability to undergo medical follow-up for the trial for geographical, social or psychological reasons.
研究组 & 干预措施
prostate cancer eligible for high-dose-rate radiotherapy
Patients with high-risk localised prostate cancer who are eligible for high-dose-rate radiotherapy
prostate cancer eligible for docetaxel chemotherapy
Patients with mHSPC eligible for docetaxel chemotherapy
prostate cancer eligible for treatment with luPSMA
Patients with mCRPC in second-line treatment eligible for treatment with luPSMA
Bladder cancer eligible for neoadjuvant chemotherapy
Patients with localised bladder cancer eligible for neoadjuvant chemotherapy
metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)
Patients with metastatic bladder cancer eligible for enfortumab vedotin (EV) plus pembrolizumab (EV-Pembro)
结局指标
主要结局
concentration of cfDNA obtained in urine
时间窗: 6 months
concentration of cfDNA obtained in urine
次要结局
- Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)(6 months)
- mutational load variation(6 months)