Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation by Human Serum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- Testosterone bioequivalents (in nanomolar)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Known or expected medical condition affecting androgens, estrogens or SHBG
排除标准
- •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
结局指标
主要结局
Testosterone bioequivalents (in nanomolar)
时间窗: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
Estradiol bioequivalents (in picomolar)
时间窗: second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval)
次要结局
- Total serum SHBG (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)(second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval))
- Calculated free and bioavailable testosterone (in nanomolar)(second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval))
- Total serum estradiol (in picomolar)(second blood sample at time of clinical follow-up (between 3 weeks and 1 year interval))