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Feasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease: a pilot study


- candidate number23414
- NTR NumberNTR5574
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2015
- Secondary IDsMEC14-295 Erasmus Medisch Centrum
- Public TitleFeasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease: a pilot study
- Scientific TitleFeasibility ex vivo Homologous Recombination Deficiency (HRD) test in advanced breast cancer disease: a pilot study
- ACRONYMex vivo HRD test
- hypothesisThis study will investigate the feasibility of HRD test in metastatic lesions of different sites among breast cancer patients who will start treatment with chemotherapy. The sites of metastatic lesions that will be investigated are: liver, lymph nodes, and subcutaneous lesions.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria• The site of the tumor should be amendable for biopsy. NB lung metastases (high risk of hematothorax) and bone metastases (not suitable for ex vivo test because calcifications interfere with experimental procedures) are excluded.
• Age >18 years
• WHO performance status 0 or 1
• Bilirubin <1.5 ULN and both AST and ALT <2,5x ULN in case a liver biopsy is planned
• Platelets > 100 x 10e9/L
• INR <1.5
• Written informed consent
- Exclusion criteriaCurrent therapeutically use of anti-coagulant (coumarin derivates, warfarin, heparin or low molecular weight heparin [LMWH]) whereby a short interruption of drug use is not allowed. LMWH if used for prophylaxis is allowed.
• Any psychological condition potentially hampering compliance with the study protocol
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 13-feb-2015
- planned closingdate
- Target number of participants0
- Interventionsna
- Primary outcomethe proportion of patients with a useful test result (Putest) will be considered as the primary end point
- Secondary outcomena
- Timepointsna
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. A. Jager
- CONTACT for SCIENTIFIC QUERIESDr. A. Jager
- Sponsor/Initiator Erasmus MC Cancer Institute, department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Alpe d’HuZes Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-nov-2015 - 27-aug-2017


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