NCT01840449已完成不适用
Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
研究概览
简要总结
The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent (also mandatory in case of retrospective documentation of subject data)
- •Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG
排除标准
- •The subject has already been included in this study
- •Participation in an interventional trial
研究组 & 干预措施
Neuroendocrine Tumours
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
干预措施: Somatuline Autogel® 60, 90 or 120 mg (Drug)
Acromegaly
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
干预措施: Somatuline Autogel® 60, 90 or 120 mg (Drug)
结局指标
主要结局
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
时间窗: Baseline and 1 year
次要结局
- Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)(Baseline and 2 years)
研究者
研究点 (3)
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