search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Detection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients a pilot study


- candidate number23601
- NTR NumberNTR5533
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2016
- Secondary IDsMEC15-419 
- Public TitleDetection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients a pilot study
- Scientific TitleDetection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients a pilot study
- ACRONYM
- hypothesisThe detection rate of leptomeningeal metastases with the CellSearch technique is higher compared to cytology.
- Healt Condition(s) or Problem(s) studiedLeptomeningeal metastases, Breast cancer
- Inclusion criteria- Breast cancer patients with clinical suspicion of leptomeningeal metastases (LM) who are planned to undergo a lumbar puncture to confirm/exclude the diagnosis LM.
- Signed informed consent.
- Exclusion criteria- Contra-indication for lumbar puncture (on the discretion of the treating neurologist).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 19-jan-2016
- planned closingdate
- Target number of participants40
- InterventionsDraw extra liquor for CSFCT during regular LP.
- Primary outcomeThe detection rate of leptomeningeal metastases as the presence of at least 1 CSFCT in liquor (independent of volume) by the CellSearch method in patients with negative CSF cytology.
- Secondary outcomeMolecular analysis of CSFCT and CTCs
- TimepointsAdditional liquor will be sent to the laboratory to detect and quantify tumor cells by the CellSearch technique. Blood draw, preferably during a blood draw that was already necessary for standard care.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A. Jager
- CONTACT for SCIENTIFIC QUERIESDr. A. Jager
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryCurrently available diagnostic techniques to diagnose LM are hampered by low sensitivity. In this pilot, we aim to improve the detection rate of LM in breast cancer patients by using the CellSearch technique, quantifying circulating tumor cells (CTCs) in cerebrospinal fluid and compare it with the current standard of care; i.e. cytopathological examination. We hypothyze that the detection rate of the CellSearch technique is higher compared to cytology.
- Main changes (audit trail)
- RECORD12-jan-2016 - 2-mei-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl