About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial population
patients with prostate or bladder cancer
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
concentration of cfDNA obtained in urine
concentration of cfDNA obtained in urine
Secondary outcomes
Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)
Distribution of circulating tumour DNA sizes in urine (urinary cfDNA)
mutational load variation
mutational load variation
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: