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

Prostate Cancer Clinical Trial

— HOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141383
• Other study ID #: IC 2021-04 HOPE
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Donors
• Prostate Cancer
• Prostatic Neoplasms

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