ProstateSynBioDiagNCT04518072
Synthetic Metabolic and Genetic Networks for Medical Diagnosics
An observational study of Prostate and Cancer, run by University Hospital, Montpellier at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)
- How many people
- 134 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jan 2021to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Montpellier, Hérault, 34000
Clinique Beau Soleil
Montpellier
About this study
Official title: 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.
Read the 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
- Being tested
- Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)
- Keywords
- marker detection, blood sample
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)Other
assessed biomarker in clinical samples
| Study group | Role | What they receive |
|---|---|---|
| Biopsy prostatic group | positive biopsy (100) negative biopsy (100) Receives: Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml) | |
| Control group | No prostate cancer (50) Receives: Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 69 months
Secondary outcomes (14)
Investigational biomarker panel for diagnosis / Prostatic specific antigen
Biospecimen retention: blood serum and urine (unit mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Creatinine
Biospecimen retention: blood serum and urine (unit µmol/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Sarcosine
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Spermine
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Ornithine
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Choline
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis /Taurine
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Fumarate
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Serotonin
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / Putrescine
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis /ribitol
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / inositol
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis / 2-oxoglutarate
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Investigational biomarker panel for diagnosis /citrate
Biospecimen retention: blood serum and urine (unit: mg/l)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start6 Jan 2021
- Primary completion19 Apr 2025
- Study completion6 Jun 2025
Why it stopped: delay in erolement, decision of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- MICALIS, CBS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518072
- Sponsor's protocol ID
- RECHMPL18_0404
- Other IDs
- 2019-A00234-53
- Acronym
- SynBioDiag
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2020
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Synthetic Metabolic and Genetic Networks for the Detection of Urogenital Cancers
- ClinicalTrials.gov ID
- NCT04518072
- Acronym / sponsor ID
- SynBioDiag / RECHMPL18_0404
- Keywords
- marker detection, blood sample
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: delay in erolement, decision of the sponsor
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- MICALIS, CBS
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopsy prostatic group | – | Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)positive biopsy (100) negative biopsy (100) |
| Control group | – | Other: Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)No prostate cancer (50) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)assessed biomarker in clinical samples | Other | Biopsy prostatic group, Control group |
Primary outcome
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.
14 secondary outcomes
Investigational biomarker panel for diagnosis / Prostatic specific antigen
Time frame: Baseline
Investigational biomarker panel for diagnosis / Creatinine
Time frame: Baseline
Investigational biomarker panel for diagnosis / Sarcosine
Time frame: Baseline
Investigational biomarker panel for diagnosis / Spermine
Time frame: Baseline
Investigational biomarker panel for diagnosis / Ornithine
Time frame: Baseline
Investigational biomarker panel for diagnosis / Choline
Time frame: Baseline
Investigational biomarker panel for diagnosis /Taurine
Time frame: Baseline
Investigational biomarker panel for diagnosis / Fumarate
Time frame: Baseline
Investigational biomarker panel for diagnosis / Serotonin
Time frame: Baseline
Investigational biomarker panel for diagnosis / Putrescine
Time frame: Baseline
Investigational biomarker panel for diagnosis /ribitol
Time frame: Baseline
Investigational biomarker panel for diagnosis / inositol
Time frame: Baseline
Investigational biomarker panel for diagnosis / 2-oxoglutarate
Time frame: Baseline
Investigational biomarker panel for diagnosis /citrate
Time frame: Baseline
Results and safety
The study was stopped early (reason given: delay in erolement, decision of the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate and Cancer, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: delay in erolement, decision of the sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to detect and quantify biomarkers such as PSA in samples using biosensors platform (time frame: Up to 69 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.