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

Completed

• Conditions: Estrogens; Hypogonadism; Testosterone; Androgens
• Interventions: Other: Serum (with or without urine) samples

• 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

Arm && Interventions

Group	Intervention	Description
Male hypogonadism	Serum (with or without urine) samples	Patients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism)
Obesity and weight loss	Serum (with or without urine) samples	Patients treated for obesity with weight loss interventions (mainly bariatric surgery)
Thyroid disorders	Serum (with or without urine) samples	Patients treated for hyperthyroidism or hypothyroidism (incl. during treatment for thyroid cancer)
Medical castration	Serum (with or without urine) samples	Patients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...)

Primary Outcome Measures

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

Secondary Outcome Measures

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