Synthetic Metabolic and Genetic Networks for Medical Diagnosics (SynBioDiag)

June 6, 2025 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ability to detect and quantify biomarkers such as PSA in samples using biosensors platform
Time Frame: Up to 69 months
The positive signal is bases on a permeation in E. coli cell membrane and recombinase switches.
Up to 69 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigational biomarker panel for diagnosis / Prostatic specific antigen
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit mg/l)
Baseline
Investigational biomarker panel for diagnosis / Creatinine
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit µmol/l)
Baseline
Investigational biomarker panel for diagnosis / Sarcosine
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / Spermine
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / Ornithine
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / Choline
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis /Taurine
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / Fumarate
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / Serotonin
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / Putrescine
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis /ribitol
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / inositol
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis / 2-oxoglutarate
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline
Investigational biomarker panel for diagnosis /citrate
Time Frame: Baseline
Biospecimen retention: blood serum and urine (unit: mg/l)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CBS
MICALIS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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