Synthetic Metabolic and Genetic Networks for Medical Diagnosics
NCT ID: NCT04518072
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
134 participants
OBSERVATIONAL
2021-01-06
2025-06-06
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Biopsy prostatic group
positive biopsy (100) negative biopsy (100)
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)
Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)
assessed biomarker in clinical samples
Interventions
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Blood sample (1 EDTA tube, 1 SST tube, 1 Streck tube) and urine sample (100 ml)
assessed biomarker in clinical samples
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient with current prostatic or urinary infection
* History of treatment for prostate cancer other than surveillance management
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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MICALIS
UNKNOWN
CBS
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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University Hospital
Montpellier, Hérault, France
Clinique Beau Soleil
Montpellier, , France
Countries
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Other Identifiers
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2019-A00234-53
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL18_0404
Identifier Type: -
Identifier Source: org_study_id
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