Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer
University Hospital, Montpellier
100 participants
May 27, 2021
INTERVENTIONAL
Conditions
Summary
The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.
Eligibility
Inclusion Criteria2
- To be male, over 18 years old
- Metastatic prostate cancer naive to any treatment or metastatic prostate cancer in biological recurrence (PSA increase) and/or clinical recurrence after hormone suppression (mCRPC)
Exclusion Criteria9
- Non-metastatic prostate cancer in biological and/or clinical recurrence after hormone-suppression (nmCRPC)
- Other active or treated cancer less than 5 years old
- Be protected by law (guardianship or curatorship)
- Be deprived of liberty by administrative decision
- Not being affiliated to a social security scheme, or not being a beneficiary of such a plan
- Being in a period of exclusion from another protocol
- Inability to understand and/or respond to questionnaires
- Inability to understand the nature, purpose and methodology of the study
- Refusal to sign informed consent
Interventions
Twenty ml of blood will be drawn from each patient : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04581109