Programme of Acromegaly Screening in Patients With Associated Somatic Disorders, Who Are Observed at the Moscow Board of Health Endocrinology Dispensary and Endocrinology Hospital at First Moscow State Medical University for the Purpose of Early Identification of the Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 367
- 试验地点
- 2
- 主要终点
- Percentage of Participants Diagnosed With Acromegaly
研究概览
简要总结
The primary objective of the protocol is to define percentage of patients with acromegaly in relation to the total number of screened patients with confirmed clinically significant set of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I, Growth Hormone, Oral Glucose-Tolerance Test [IGF-1, GH, OGTT]) and instrumental examination methods (Magnetic Resonance Imaging [MRI]).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years and above with associated somatic disorders observed at the Moscow Endocrinology dispensary or Endocrinology Hospital at First Moscow State Medical University
- •Patients who signed the Informed Consent Form for participation in the survey before collection of any information.
排除标准
- •Patient already diagnosed with acromegaly
- •Patient's refusal to participate in the survey.
结局指标
主要结局
Percentage of Participants Diagnosed With Acromegaly
时间窗: Participants were screened over approximately 21 months
Acromegaly is an acquired pathological condition related to excessive production of growth hormone and characterized by somatic disfigurement and multiple systemic manifestations. The percentage of participants with acromegaly was determined in participants with a confirmed clinically significant set of associated somatic disorders using biochemical assays (IGF-1, GH, OGTT) and instrumental examination methods (MRI).
次要结局
- Percentage of Participants With Associated Concurrent Somatic Disorders(At baseline (Day 1))
- Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly(Participants were screened over approximately 21 months)
- Percentage of Participants With Microadenomas and Macroadenomas(Participants were screened over approximately 21 months)
- Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)(Participants were screened over approximately 21 months)