Clinical trial NCT04518072: Synthetic Metabolic and Genetic Networks for Medical Diagnosics
Official title: Development of Synthetic Metabolic and Genetic Networks for the Detection of Urogenital Cancers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate
Cancer
Keywords: marker detection
blood sample
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: MICALIS
name: CBS
First posted: 2020-08-19
Enrollment: 134
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Ability to detect and quantify biomarkers such as PSA in samples using biosensors platform
timeFrame: Up to 69 months
Secondary outcomes:
measure: Investigational biomarker panel for diagnosis / Prostatic specific antigen
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Creatinine
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Sarcosine
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Spermine
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Ornithine
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Choline
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis /Taurine
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Fumarate
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Serotonin
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / Putrescine
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis /ribitol
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / inositol
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis / 2-oxoglutarate
timeFrame: Baseline
measure: Investigational biomarker panel for diagnosis /citrate
timeFrame: Baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
state: Hérault
city: Montpellier
country: France
facility: Clinique Beau Soleil
Study officials:
References: