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HOPE: Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy

Sponsor
Institut Curie (Other)
Overall Status
Recruiting
CT.gov ID
NCT05141383
Collaborator
(none)
118
Enrollment
1
Location
3
Arms
60
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Urine sampling
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3 cohorts will be included in the study: 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.3 cohorts will be included in the study: 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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy
Actual Study Start Date :
May 4, 2022
Anticipated Primary Completion Date :
Sep 4, 2023
Anticipated Study Completion Date :
May 4, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with prostate cancer

Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml

Other: Urine sampling
A blood sample and a urine sample after prostate massage will be carried out at baseline
Other Names:
  • Blood sampling

    		•
    Other: 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

    Other: Urine sampling
    A blood sample and a urine sample after prostate massage will be carried out at baseline
    Other Names:
  • Blood sampling

    		•
    Other: Healthy donors

    Male from 50 to 70 years old with a PSA level <4 ng / mL

    Other: Urine sampling
    A blood sample and a urine sample after prostate massage will be carried out at baseline
    Other Names:
  • Blood sampling

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Extracting extravesicular particles and RNA from urine fluids [Baseline]

      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.

    Secondary Outcome Measures

    1. Extracting extravesicular particles and RNA from blood [Baseline]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Concerning patients:

    1. / Patients with suspected prostate cancer (MRI or digital rectal examination), or prostatic hyperplasia with a PSA level> 4 ng / ml

    2. / Patients with cancer detected after biopsy including 3 groups of 10 patients with Gleason score> = 8 (High Risk), 7 (intermediate Risk), or <= 6 (low risk)

    3. / Patients diagnosed by prostate MRI in the course of treatment

    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 (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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Curie Paris France 75005

    Sponsors and Collaborators

    • Institut Curie

    Investigators

    • Principal Investigator: Yves ALLORY, MD PhD, Institut Curie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Curie
    ClinicalTrials.gov Identifier:
    NCT05141383
    Other Study ID Numbers:
    • IC 2021-04
    First Posted:
    Dec 2, 2021
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut Curie
    diagnostic
    prognosis
    prostate cancer
    long non-coding RNA biomarkers
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of May 6, 2022