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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02694-45 | Registry Identifier | ID-RCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| concentration of cfDNA obtained in urine | concentration of cfDNA obtained in urine | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of circulating tumour DNA sizes in urine (urinary cfDNA) | Distribution of circulating tumour DNA sizes in urine (urinary cfDNA) | 6 months |
| mutational load variation | mutational load variation |
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Inclusion Criteria:
1) Five patients for each of the following cancers :
Exclusion Criteria:
Men for Prostate Cancer Men or Women for bladder cancer
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patients with prostate or bladder cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia HIMPE | Contact | +33 240679747 | promotionrc@ico.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Manon MD DE VRIES BRILLAND | ICO Angers | Principal Investigator |
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Obtaining preliminary data and evaluation of feasibility
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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urine samples
| 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |