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Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation

Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02434562
Enrollment
73
Registered
2015-05-05
Start date
2012-04-30
Completion date
2016-09-30
Last updated
2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgens, Estrogens, Hypogonadism, Testosterone

Brief summary

This is a prospective biobank set up to collect serum from patients with disorders associated with changes in androgens, estrogens or sex hormone-binding globulin (SHBG), before and/or after treatment.

Detailed description

In vitro cell-based bioassays may be a technique to measure serum androgen or estrogen bioactivity. In this study investigators are collecting serum (and if possible, urine) samples from different cohorts of patients, before and/or after treatment. The aim is to measure androgens, estrogens and SHBG as well as in vitro bioactivity with newly developed cell-based bioassays, and to compare different techniques to each other as well as to clinical endpoints available in the patient's Electronic Health Record.

Interventions

OTHERSerum (with or without urine) samples

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Known or expected medical condition affecting androgens, estrogens or SHBG

Exclusion criteria

* Inability to provide written informed consent * Known or suspected bloodborne infectious diseases (e.g. HIV, viral hepatitis etc.) * Anemia (\<11 g/dL hemoglobin) or being a Jehovah's Witness

Design outcomes

Primary

MeasureTime frame
Testosterone bioequivalents (in nanomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Estradiol bioequivalents (in picomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

Secondary

MeasureTime frameDescription
Total serum testosterone (in nanomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)Measured by immunoassay or liquid chromatography tandem mass spectrometry (LC-MS/MS)
Calculated free and bioavailable testosterone (in nanomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Total serum SHBG (in nanomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)Measured by immunoassay
Total serum estradiol (in picomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)Measured by immunoassay or LC-MS/MS
Calculated free and bioavailable estradiol (in picomolar)second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026