NCT02231593已完成不适用
Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 71
- 试验地点
- 20
- 主要终点
- Number of acromegaly patients classified using SAGIT
研究概览
简要总结
The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies.
In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.
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
- •Male or female aged 18 years-old or above
- •Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)
- •Controlled/stable, active and treatment naïve patients.
- •Patient with the cognitive and linguistic capacities to understand the information letter of the study
- •Patient who signed informed consent
排除标准
- •History of non-compliance or inability to reliably receive treatment in the foreseeable future
- •Gaps in treatment of greater than 1 month within the 12 months prior to study entry
结局指标
主要结局
Number of acromegaly patients classified using SAGIT
时间窗: 8 months
次要结局
未报告次要终点
研究者
研究点 (20)
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