Cancer Clinical Trial
— SynBioDiagOfficial 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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | July 6, 2027 |
Est. primary completion date | July 6, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Clinique Beau Soleil | Montpellier | |
France | University Hospital | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | CBS, MICALIS |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of adenocarcinoma of the prostate | Number of patients clinically diagnosed with prostate adenocarcinoma | Up to three years | |
Secondary | Investigational biomarker panel for diagnosis / Prostatic specific antigen | Biospecimen retention: blood serum and urine (unit mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Creatinine | Biospecimen retention: blood serum and urine (unit µmol/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Sarcosine | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Spermine | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Ornithine | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Choline | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis /Taurine | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Fumarate | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Serotonin | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / Putrescine | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis /ribitol | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / inositol | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis / 2-oxoglutarate | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline | |
Secondary | Investigational biomarker panel for diagnosis /citrate | Biospecimen retention: blood serum and urine (unit: mg/l) | Baseline |
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