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

January 23, 2017 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

73

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in the department of Endocrinology/Andrology, Urology and Oncology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medical castration
Patients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...)
Other: Serum (with or without urine) samples
Male hypogonadism
Patients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism)
Other: Serum (with or without urine) samples
Thyroid disorders
Patients treated for hyperthyroidism or hypothyroidism (incl. during treatment for thyroid cancer)
Other: Serum (with or without urine) samples
Obesity and weight loss
Patients treated for obesity with weight loss interventions (mainly bariatric surgery)
Other: Serum (with or without urine) samples
Miscellaneous
Various disorders associated with alterations in SHBG, androgens and/or estrogens

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
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)
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
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)
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
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
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
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
second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Dirk Vanderschueren, MD, PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s54034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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