No registrations found.
ID
Source
Health condition
breast cancer, estrogen receptor positive
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ratio between endoxifen serum concentrations and endoxifen dried blood spot concentrations
Secondary outcome
N/A
Background summary
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.
Study objective
Tamoxifen and endoxifen serum concentrations are linearly related to DBS concentration
Study design
1 timepoint; a paired sample will be obtained a serum sample and a dried blood spot sample
Intervention
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.
Inclusion criteria
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.
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3881 |
NTR-old | NTR4042 |
CCMO | NL41454.031.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON37023 |