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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.
Multicenter, RIPH 2 study, evaluating on 3 patient cohorts the feasibility of setting up a diagnostic test, prognosis and active surveillance of prostate cancer using long non-coding RNA biomarkers.
For patients agreeing to participate in the study and having signed a consent form, during their routine care consultation in the urology department, will have a blood sample and a urine sample after prostate massage as part of the study, and if necessary, a tissue sample as part of the treatment.
Patients with prostate cancer will be followed as part of their care at least annually, and their follow-up data will be collected as part of the study, without additional sampling.
A blood sample and a urine sample after prostate massage will be carried out during a single consultation at the CIC Henri Mondor for
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with prostate cancer | Other | Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml |
|
| Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate | Other | Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml |
|
| Healthy donors | Other | Male from 50 to 70 years old with a PSA level <4 ng / mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine sampling | Other | A blood sample and a urine sample after prostate massage will be carried out at baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Concerning patients:
Regarding healthy volunteers:
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.
Prostate cancer or suspicion of prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Yves ALLORY, MD PhD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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3 cohorts of 118 patients in the aim to have 90 evaluable participants will be included in the study:
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |