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Clinical evaluation of dried blood spots obtained from a fingerprick for the determination of tamoxifen and endoxifen levels


- candidate number15018
- NTR NumberNTR4042
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2013
- Secondary IDsNL41454.031.12  METC AvL
- Public TitleClinical evaluation of dried blood spots obtained from a fingerprick for the determination of tamoxifen and endoxifen levels
- Scientific TitleClinical evaluation of dried blood spots for the determination of tamoxifen and endoxifen levels
- ACRONYM
- hypothesisTamoxifen and endoxifen serum concentrations are linearly related to DBS concentration
- Healt Condition(s) or Problem(s) studiedBreast cancer, Estrogen receptor positive
- Inclusion criteria1. Treated with tamoxifen;
2. Age minimum 18 years;
3. Able and willing to give written informed consent;
4. Able and willing to undergo a fingerprick voor dried blood spot sampling.
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 18-mrt-2013
- planned closingdate1-okt-2013
- Target number of participants50
- InterventionsPatients are treated with tamoxifen on a dose according to the prescription of the physician. No further intervention is needed. A DBS sample will be obtained simultaneously with the serum sample that is obtained for regular clinical care.
- Primary outcomeRatio between endoxifen serum concentrations and endoxifen dried blood spot concentrations
- Secondary outcomeN/A
- Timepoints1 timepoint; a paired sample will be obtained a serum sample and a dried blood spot sample
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N.G.L. Jager
- CONTACT for SCIENTIFIC QUERIES N.G.L. Jager
- Sponsor/Initiator Slotervaart Hospital
- Funding
(Source(s) of Monetary or Material Support)
Bioanalytical Laboratory of Slotervaarthospital
- PublicationsN/A
- Brief summaryDBS samples to determine the pharmacokinetics of tamoxifen in a ‘real life’ cohort will be collected during a routine visit to the Antoni van Leeuwenhoek hospital where a serum sample is obtained as part of clinical care.
No relationship between DBS and serum concentrations has been established yet for tamoxifen and endoxifen. This would enable sample collection by means of a simple fingerprick. The DBS to serum ratio of tamoxifen and endoxifen has to be defined in simultaneously drawn DBS and serum samples of patients using tamoxifen.
- Main changes (audit trail)
- RECORD21-jun-2013 - 8-jul-2013


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