Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Drug utilization patterns as assessed by chart review
研究概览
简要总结
This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.
详细描述
This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome.
Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients
Data to be collected from a retrospective chart review will include:
- Patient demographics
- Medical history
- Pre and post treatment clinical assessments and laboratory results
- Radiologic findings (if available)
- Adverse events
Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatrics (age≤21 years) at time Korlym initiation
- •Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
- •Received at least one dose of Korlym
- •Availability of pre-treatment (baseline) and follow-up data
排除标准
- 未提供
结局指标
主要结局
Drug utilization patterns as assessed by chart review
时间窗: Length of Korlym therapy, up to 5 years
The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym
次要结局
- Weight as assessed by chart review(Length of Korlym therapy, up to 5 years)
- Blood Pressure as assessed by chart review(Length of Korlym therapy, up to 5 years)