NCT04518072

Brief Summary

This is a category 3 human study, prospective, comparative, in parallel groups. A comparative qualitative and quantitative analysis of several markers in 250 samples is proposed.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

4.3 years

First QC Date

July 1, 2020

Last Update Submit

June 6, 2025

Conditions

ProstateCancer

Keywords

marker detectionblood sample

Outcome Measures

Primary Outcomes (1)

  • Ability to detect and quantify biomarkers such as PSA in samples using biosensors platform

    The positive signal is bases on a permeation in E. coli cell membrane and recombinase switches.

    Up to 69 months

Secondary Outcomes (14)

  • Investigational biomarker panel for diagnosis / Prostatic specific antigen

    Baseline

  • Investigational biomarker panel for diagnosis / Creatinine

    Baseline

  • Investigational biomarker panel for diagnosis / Sarcosine

    Baseline

  • Investigational biomarker panel for diagnosis / Spermine

    Baseline

  • Investigational biomarker panel for diagnosis / Ornithine

    Baseline

  • +9 more secondary outcomes

Study Arms (2)

Biopsy prostatic group

positive biopsy (100) negative biopsy (100)

Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)

Control group

No prostate cancer (50)

Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)

Interventions

Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)OTHER

assessed biomarker in clinical samples

Biopsy prostatic groupControl group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe study will compare two groups of patients with prostate cancer and controls.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted for prostate disease with a negative or positive PSA blood test may be included in the study if they meet the inclusion criteria. During the consultation, the investigator will check the eligibility of the subject against the criteria of eligibility. The investigator will present and explain the nature of the study so that the subject knows his rights and responsibilities, as well as the risks and possible benefits of the study. The duration of this visit will be approximately 1 hour. The PSA value will be collected for the group Patients-biopsy at 1 year follow-up.

You may qualify if:

  • Men aged over 18
  • Informed, written consent of the patient for the biological collection
  • Subject affiliated to a French social security scheme or beneficiary of such a scheme
  • \- Admitted to care prostate disease or suspicion of prostate cancer and with a positive or negative PSA blood result
  • \- Man free from all prostate or bladder pathologies

You may not qualify if:

  • Patient under legal protection
  • Persons deprived of their liberty, protected adults or vulnerable persons
  • Participants may withdraw their consent at any time and for any reason whatsoever without incurring any negative consequences without change in their usual care
  • Patient with current prostatic or urinary infection
  • History of treatment for prostate cancer other than surveillance management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Montpellier, Hérault, 34000, France

Location

Clinique Beau Soleil

Montpellier, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (1 EDTA tube, 1 Streck tube, 1 SST tube) and urine sample (100 ml)

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

August 19, 2020

Study Start

January 6, 2021

Primary Completion

April 19, 2025

Study Completion

June 6, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Locations

FR(2)