Prostate Cancer Clinical Trial
— HOPEOfficial title:
Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy
Constitution of a biological collection within the framework of the establishment of a diagnostic, prognostic and active surveillance test for prostate cancer from long non-coding RNA biomarkers, in 3 cohorts of patients, with cancer of the prostate, with suspected cancer without biopsy confirmation or with prostatic hyperplasia and healthy donors. This biological collection will also be used as a support for further researches on the identification of biomarkers and genetic markers to improve the prognosis and diagnostic management of patients with prostate pathologies.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 24, 2024 |
Est. primary completion date | October 24, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years to 70 Years |
Eligibility | Inclusion Criteria: Concerning patients: 1. / Patient with suspected prostate cancer or prostatic hyperplasia with a PSA level = 4 ng / ml 2. / Patient diagnosed by prostate MRI in the course of treatment 3. / No infectious episode in the week before the visit (in particular no urinary tract infection) documented by dipstick and absence of fever 4. / Information of the patient and signature of informed consent or his legal representative. 5. / Participant affiliated to a social security scheme Regarding healthy volunteers: 1. / Male from 50 to 70 years old 2. / PSA level < 4 ng / mL 3. / No infectious episode in the week before the visit (in particular no urinary tract infection), documented by dipstick and the absence of fever 4. / Absence of cancer and history of haematological pathologies < 5 years (in particular leukemia, lymphoma). 5. / Patient information and signature of consent Exclusion Criteria: 1 / Participants who refused to participate in the biological collection 2) Persons deprived of their liberty or under guardianship. 3) Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons. |
Country | Name | City | State |
---|---|---|---|
France | Institut Curie | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut Curie |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extracting extravesicular particles and RNA from urine fluids | Criteria will be a minimum of 10ng of total RNA extracted per sample total RNA sequencing and greater than 10 million unique reads mapping to the Gencode V32 reference genome. | Baseline | |
Secondary | Extracting extravesicular particles and RNA from blood | Criteria will be a minimum of 10ng of total RNA extracted per sample total RNA sequencing and greater than 10 million unique reads mapping to the Gencode V32 reference genome. | Baseline |
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