Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy (HOPE)
NCT ID: NCT05141383
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2022-05-04
2024-09-03
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
* 40 patients with prostate cancer, or
* 40 patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate and
* 38 healthy donors.
DIAGNOSTIC
NONE
Study Groups
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Patients with prostate cancer
Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level\> 4 ng / ml
Urine sampling
A blood sample and a urine sample after prostate massage will be carried out at baseline
Patients with suspected cancer without confirmation on biopsy, or with hyperplasia of the prostate
Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level\> 4 ng / ml
Urine sampling
A blood sample and a urine sample after prostate massage will be carried out at baseline
Healthy donors
Male from 50 to 70 years old with a PSA level \<4 ng / mL
Urine sampling
A blood sample and a urine sample after prostate massage will be carried out at baseline
Interventions
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Urine sampling
A blood sample and a urine sample after prostate massage will be carried out at baseline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
50 Years
70 Years
MALE
Yes
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Yves ALLORY, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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Institut Curie
Paris, , France
Countries
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Other Identifiers
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IC 2021-04
Identifier Type: -
Identifier Source: org_study_id
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