Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05141383
Other study ID # IC 2021-04 HOPE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2022
Est. completion date October 24, 2024

Study information

Verified date April 2024
Source Institut Curie
Contact Sandra NESPOULOUS
Phone +331 56 24 56 30
Email drci.promotion@curie.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Institut Curie Paris

Sponsors (1)

Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A