Tamoxifen and endoxifen serum concentrations are linearly related to DBS concentration
ID
Bron
Aandoening
breast cancer, estrogen receptor positive
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ratio between endoxifen serum concentrations and endoxifen dried blood spot concentrations
Achtergrond van het onderzoek
DBS 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.
Doel van het onderzoek
Tamoxifen and endoxifen serum concentrations are linearly related to DBS concentration
Onderzoeksopzet
1 timepoint; a paired sample will be obtained a serum sample and a dried blood spot sample
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
None
Opzet
Deelname
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Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3881 |
NTR-old | NTR4042 |
CCMO | NL41454.031.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON37023 |