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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypogonadism, Estrogens, Testosterone, Androgens

Intervention / Treatment
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* Other: Serum (with or without urine) samples


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone bioequivalents (in nanomolar) |  | second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval) | 
| Estradiol bioequivalents (in picomolar) |  | 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) |  | second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval) | 
| Calculated free and bioavailable estradiol (in picomolar) |  | second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval) | 
| 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) | 
| 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) | 
| Total serum SHBG (in nanomolar) | Measured by immunoassay | second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval) |