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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Androgens; Hypogonadism; Testosterone; Estrogens

Treatments: Other: Serum (with or without urine) samples

Study type: Observational

Funder types: Other

Identifiers

NCT02434562

s54034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

73 participants in 5 patient groups

Medical castration

Description:

Patients treated with androgen deprivation therapy (e.g. for hypersexuality, transgender subjects, ...)

Treatment:

Other: Serum (with or without urine) samples

Male hypogonadism

Description:

Patients treated with testosterone replacement therapy (e.g. for late-onset hypogonadism, secondary hypogonadism)

Treatment:

Other: Serum (with or without urine) samples

Thyroid disorders

Description:

Patients treated for hyperthyroidism or hypothyroidism (incl. during treatment for thyroid cancer)

Treatment:

Other: Serum (with or without urine) samples

Obesity and weight loss

Description:

Patients treated for obesity with weight loss interventions (mainly bariatric surgery)

Treatment:

Other: Serum (with or without urine) samples

Miscellaneous

Description:

Various disorders associated with alterations in SHBG, androgens and/or estrogens