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

Completed

• Conditions: Estrogens; Hypogonadism; Testosterone; Androgens

• Registration Number: NCT02434562
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-05
• Status Verified: 2016-05
• Primary Completion: 2016-09
• Study Completion: 2016-09-30
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total serum SHBG (in nanomolar)	second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)	Measured by immunoassay
Calculated free and bioavailable estradiol (in picomolar)	second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
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 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