NCT03220087已完成不适用
Study to Evaluate the Use of Resources and the Costs Associated With Controlled or Uncontrolled Carcinoid Syndrome in Patients With Neuroendocrine Tumours (NETs) in Spain
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
- 142
- 试验地点
- 28
- 主要终点
- Use of resources and costs in patients with controlled or uncontrolled CS
研究概览
简要总结
The objective of this study is to describe the use of resources and the costs associated with controlled or uncontrolled CS in patients with NETs in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patient 18 years of age or older.
- •Patient with a diagnosis of NET (G1 or G2) treated with Somatostatin Analogues (SSAs) to manage their symptoms.
- •Group A: patient who has had at least one episode of uncontrolled CS, according to medical criteria, since the start of treatment.
- •Group B: patient who has not had any episode of uncontrolled CS, according to medical criteria, in the last 12 months.
- •Patient able to read and understand the study questionnaires.
- •Patient who has given written informed consent to participate in the study.
排除标准
- •Patient participating in another clinical study when invited to participate in this study.
- •Patient with another severe malignant disease.
- •Patient who cannot meet the requirements established in the protocol (non-compliant or unfit to fill in the questionnaires).
- •Patient with symptoms or diseases that could be confused with CS or render CS more difficult to evaluate: right cardiomyopathy or diarrhoea of any aetiology other than NET.
结局指标
主要结局
Use of resources and costs in patients with controlled or uncontrolled CS
时间窗: Day 1 (Group A retrospective data collection - 3 months before and up to 6/12 months after the last uncontrolled carcinoid episode. Group B retrospective data collection - up to 6/12 months before the date of enrolment)
次要结局
- Relationship between the state of health perceived by the patient and the clinical status of the disease reported by the physician.(Day 1 (Group A retrospective data collection - 3 months before and up to 6/12 months after the last uncontrolled carcinoid episode. Group B retrospective data collection - up to 6/12 months before the date of enrolment))
- Clinical characteristics and therapeutic management of patients with NET and controlled or uncontrolled CS(Day 1 (Group A retrospective data collection - 3 months before and up to 6/12 months after the last uncontrolled carcinoid episode. Group B retrospective data collection - up to 6/12 months before the date of enrolment))
研究者
研究点 (28)
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