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Trial record 33 of 213 for:    "Hypogonadism" | "Androgens"

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

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ClinicalTrials.gov Identifier: NCT02434562
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment
Hypogonadism Estrogens Testosterone Androgens Other: Serum (with or without urine) samples

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.


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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum
Study Start Date : April 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 30, 2016

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



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Serum and urine


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients in the department of Endocrinology/Andrology, Urology and Oncology
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434562


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Dirk Vanderschueren, MD, PhD UZ Leuven

Publications of Results:
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02434562     History of Changes
Other Study ID Numbers: s54034
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: May 2016
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases