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Early Detection of Prostate Cancer
Sponsor: University Hospital, Montpellier
Summary
This study is the early detection of prostate cancer by analysing circulating bloodbased biomarkers. Based on our latest developments, we primarily aim to assess the validity of CTCs (circulating tumour cells) and tumour cell products circulating in blood (DNA, exosomes) for early PCa (Prostate cancer) detection. In the first discovery period, the investigators will assess which Liquid biopsy marker will provide the best discrimination between the patients with histologically proven PCa and age-matched noncancer controls. Further subset analysis with special emphasis on the identification of high risk PCa patients with aggressive tumours as defined by a Gleason score ("gold standard") of 8 or higher (ISUP 4 and higher), will be performed. The resulting biomarker candidates will then be further explored in the subsequent training and validation study (years 2 and 3) in order to obtain the single blood test or combination of tests with the highest sensitivity and specificity for detection of early PCa and/or high-risk PCa. The investigators will also compare these new biomarkers with recently FDA cleared CE-IVD assays for early detection of prostate cancer, based on classic peripheral tumour markers, such as Prostate Health Index (PHI) and PCA3. Follow up evaluations will be initiated to assess the prognostic relevance of the candidate biomarkers determined in this project. Here, the investigators will set up the data management system including all relevant information on the tissues collected and the results of the analyses as well as the clinical data of the patients investigated in this study.
Official title: Early Detection of Prostate Cancer by Liquid Biopsy
Key Details
Gender
MALE
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2021-02-19
Completion Date
2033-09-15
Last Updated
2022-01-04
Healthy Volunteers
No
Conditions
Interventions
Blood sample
Per patient 49 ml of peripheral blood sample : * 21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis; * 28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation.
Locations (4)
CHU Montpellier - Département d'urologie et transplantation rénale
Montpellier, France
CHU Montpellier - Laboratoire des Cellules Circulantes Rares Humaines
Montpellier, France
Clinique Beau Soleil - Service d'urologie
Montpellier, France
CHU de Nîmes - Service Urologie Andrologie Sexologie
Nîmes, France