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Generation of circulating tumor cell derived organoids through enrichment by leukapheresis - A novel drug screening system in metastatic prostate cancer


- candidate number25640
- NTR NumberNTR6150
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-dec-2016
- Secondary IDsMEC-2016-449 // NL57710.078.16. METC // ABR-nummer
- Public TitleGeneration of circulating tumor cell derived organoids through enrichment by leukapheresis - A novel drug screening system in metastatic prostate cancer
- Scientific TitleGeneration of circulating tumor cell derived organoids through enrichment by leukapheresis - A novel drug screening system in metastatic prostate cancer
- ACRONYMCIRCLE study
- hypothesisWe hypothesize that it is possible to culture circulating tumor cells obtained by leukapheresis into organoids.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria- Metastatic prostate cancer.
- Intention to start (new) line of systemic treatment.
- Written informed consent of the patient.
- Age ≥ 18 years.
- WHO performance status ≤2.
- ≥ 2 adequate peripheral veins as access point for leukapheresis.
- Exclusion criteria- Low CTC count.
- Patients with a known hypersensitivity to the used LA-anticoagulant (ACD).
- Current ADT
- Hemorrhage disease and/or coagulation disorder.
- Inadequate liver function.
- Inadequate renal function.
- Inadequate hematology and coagulation status.
- Use of anticoagulation at time of leukapheresis, unless medication can either be safely stopped or counteracted.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 7-dec-2016
- planned closingdate31-dec-2018
- Target number of participants46
- Interventionsleukapheresis
- Primary outcomeThe rate of successfully cultured organoids from CTCs obtained by LA.
- Secondary outcomeThe collection efficiency of CTCs by LA.
- TimepointsEnrolment should be completed within 2 years.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.F. van Dessel
- CONTACT for SCIENTIFIC QUERIES Martijn P. Lolkema
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Alpe díHuZes Foundation, KWF Kankerbestrijding
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-dec-2016 - 7-feb-2017


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