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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04518072
Other study ID # RECHMPL18_0404
Secondary ID 2019-A00234-53
Status Recruiting
Phase
First received
Last updated
Start date January 6, 2021
Est. completion date July 6, 2027

Study information

Verified date January 2024
Source University Hospital, Montpellier
Contact Jerome SOLASSOL, PHD
Phone 04.67.33.58.76
Email j-solassol@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The assumption is that researchers can engineer synthetic metabolic and genetic networks to expand the panel of molecules that are currently known to be detected by natural systems. The investigators also hypothesize synthetic metabolic and genetic networks can be tuned for decisions making and in particular to diagnose diseases from biomarkers detections. This project proposes for the first time a hybrid analogue / digital solution for the multiplexed detection of biomarkers using bacterial and paper-based biosensors. Biosensors can be designed using analog or digital devices. Digital devices in synthetic and natural systems are noise-resistant and useful for decision-making. Analog devices are useful for signal transmission and processing. Here the investigators take advantage of signal transmission and processing via analog transducers and adders, and then decision-making via genetic switches. Such a hybrid analogue / digital approach has not yet been developed for biosensing. Another novelty of the project is to use synthetic metabolic pathways to develop analog devices. The advantage in term of treatment, for example, consists in the fact that the speed of enzymatic reactions in an analog adder far exceeds the speed of gene expression required to create a genetic logic matrix; it becomes even more pronounced when the devices are connected in series. The methodology will be illustrated for the detection of biomarkers of prostate tumors, but it is broad enough to be applicable to other diagnoses. The choice to develop biosensors for prostate disease is of practical relevance since the current screening strategy (based on PSA measurement) can lead to overdiagnosis and cannot differentiate between patients with aggressive tumors and those with an indolent illness.This study propose to mainly develop a bacterial and paper-based biosensor system


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date July 6, 2027
Est. primary completion date July 6, 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Patients specific inclusion criteria : - Admitted to care prostate disease or suspicion of prostate cancer and with a positive or negative PSA blood result Controls specific inclusion criteria : - Man free from all prostate or bladder pathologies Exclusion Criteria: - 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 Controls specific non-inclusion criteria : - Patient with current prostatic or urinary infection - History of treatment for prostate cancer other than surveillance management

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)
assessed biomarker in clinical samples

Locations

Country Name City State
France Clinique Beau Soleil Montpellier
France University Hospital Montpellier Hérault

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Montpellier CBS, MICALIS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of adenocarcinoma of the prostate Number of patients clinically diagnosed with prostate adenocarcinoma Up to three years
Secondary Investigational biomarker panel for diagnosis / Prostatic specific antigen Biospecimen retention: blood serum and urine (unit mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Creatinine Biospecimen retention: blood serum and urine (unit µmol/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Sarcosine Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Spermine Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Ornithine Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Choline Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis /Taurine Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Fumarate Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Serotonin Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / Putrescine Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis /ribitol Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / inositol Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis / 2-oxoglutarate Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
Secondary Investigational biomarker panel for diagnosis /citrate Biospecimen retention: blood serum and urine (unit: mg/l) Baseline
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