Synthetic Metabolic and Genetic Networks for Medical Diagnosics (SynBioDiag)

Development of Synthetic Metabolic and Genetic Networks for the Detection of Urogenital Cancers

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Prostate
• Intervention / Treatment: Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Clinique Beau Soleil
  • Hérault
    • Montpellier, Hérault, France, 34000
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); assessed biomarker in clinical samples
Control group; No prostate cancer (50)	Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml); assessed biomarker in clinical samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigational biomarker panel for diagnosis / Prostatic specific antigen	Biospecimen retention: blood serum and urine (unit mg/l)	Baseline
Investigational biomarker panel for diagnosis / Creatinine	Biospecimen retention: blood serum and urine (unit µmol/l)	Baseline
Investigational biomarker panel for diagnosis / Sarcosine	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / Spermine	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / Ornithine	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / Choline	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis /Taurine	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / Fumarate	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / Serotonin	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / Putrescine	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis /ribitol	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / inositol	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis / 2-oxoglutarate	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline
Investigational biomarker panel for diagnosis /citrate	Biospecimen retention: blood serum and urine (unit: mg/l)	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: CBS; MICALIS

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): April 19, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: blood sample; marker detection
• Other Study ID Numbers: RECHMPL18_0404; 2019-A00234-53 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No