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Completed

NCT Number: NCT02434562

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

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.

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Key information

Conditions

Hypogonadism Androgens Endocrine System Diseases Estrogens Gonadal Disorders Testosterone

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum (with or without urine) samples

Other

Primary outcomes

  1. Testosterone bioequivalents (in nanomolar)

    Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  2. Estradiol bioequivalents (in picomolar)

    Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

Secondary outcomes

  1. Calculated free and bioavailable testosterone (in nanomolar)

    Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  2. Calculated free and bioavailable estradiol (in picomolar)

    Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

  3. Total serum testosterone (in nanomolar)

    Time frame: 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)

  4. Total serum estradiol (in picomolar)

    Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

    Measured by immunoassay or LC-MS/MS

  5. Total serum SHBG (in nanomolar)

    Time frame: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

    Measured by immunoassay

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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