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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434562
• Other study ID #: s54034
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: January 23, 2017
• Start date: April 2012
• Est. completion date: September 30, 2016

Study information

• Verified date: May 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 30, 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Androgens
• Estrogens
• Hypogonadism
• Testosterone

Intervention

Other:
• Serum (with or without urine) samples

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

References & Publications (1)

Laurent MR, Helsen C, Antonio L, Schollaert D, Joniau S, Vos MJ, Decallonne B, Hammond GL, Vanderschueren D, Claessens F. Effects of sex hormone-binding globulin (SHBG) on androgen bioactivity in vitro. Mol Cell Endocrinol. 2016 Dec 5;437:280-291. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone bioequivalents (in nanomolar)		second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Primary	Estradiol bioequivalents (in picomolar)		second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Secondary	Calculated free and bioavailable testosterone (in nanomolar)		second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Secondary	Calculated free and bioavailable estradiol (in picomolar)		second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Secondary	Total serum testosterone (in nanomolar)	Measured by immunoassay or liquid chromatography tandem mass spectrometry (LC-MS/MS)	second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Secondary	Total serum estradiol (in picomolar)	Measured by immunoassay or LC-MS/MS	second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Secondary	Total serum SHBG (in nanomolar)	Measured by immunoassay	second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)