Clinical evaluation of dried blood spot (DBS) assay, by determining the ratio between DBS and serum levels of tamoxifen and endoxifen and to investigate if patients can obtain useful DBS at home.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Ratio of the DBS and serum concentrations of tamoxifen and endoxifen
Secondary outcome
- Percentage of patients that obtains a DBS by self-sampling at home
- Percentage of patients that provides DBS samples useful for analysis
Background summary
Tamoxifen, a selective estrogen receptor modulator, is widely used for the
treatment and prevention of breast cancer. The steady state concentration of
its most active metabolite, endoxifen, is a proposed predictor of tamoxifen
efficacy. It is suggested that there is a minimum serum concentration above
which endoxifen is effective against the recurrence of breast cancer. Current
practice is to analyze tamoxifen and metabolite concentrations in serum, blood
samples are collected when patients visit the Antoni van Leeuwenhoekhospital.
Study objective
Clinical evaluation of dried blood spot (DBS) assay, by determining the ratio
between DBS and serum levels of tamoxifen and endoxifen and to investigate if
patients can obtain useful DBS at home.
Study design
Patients treated with tamoxifen who undergo venapuncture are asked if they are
willing to obtain a DBS sample at the same time. For the feasiblity part,
patients are asked if they are willing to self-obtain a DBS sample through a
fingerprick. They will be instructed at the Antoni van Leeuwenhoekhospital.
Study burden and risks
not applicable
Louwesweg 6
Amsterdam 1066EC
NL
Louwesweg 6
Amsterdam 1066EC
NL
Listed location countries
Age
Inclusion criteria
- Treated with tamoxifen
- Age 18 years or older
- Able and willing to give informed consent
- Able and willing to undergo a fingerprick for dried blood spot sampling
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL47958.031.14 |