Clinical trial NCT02434562: Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation
Official title: Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Estrogens
Testosterone
Androgens
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the department of Endocrinology/Andrology, Urology and Oncology

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.

Eligibility criteria: 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

Primary outcomes:
measure: Testosterone bioequivalents (in nanomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
measure: Estradiol bioequivalents (in picomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Secondary outcomes:
measure: Calculated free and bioavailable testosterone (in nanomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
measure: Calculated free and bioavailable estradiol (in picomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
measure: Total serum testosterone (in nanomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
measure: Total serum estradiol (in picomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
measure: Total serum SHBG (in nanomolar)
timeFrame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Other outcomes:
Locations:
Study officials:
affiliation: UZ Leuven
name: Dirk Vanderschueren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1016/j.mce.2016.08.041. Epub 2016 Aug 26.