The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN
研究概览
简要总结
This is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of Time To Switch (TTS) from first-line to second-line medical therapy in Acromegaly.
详细描述
The study will retrospectively collect clinical, laboratory and anamnestic data of approximately 100 patients evaluated at the UOs involved in the study in last 5 years and 6 months.
Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide LAR or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of GH levels ≥1 μg/L and IGF-1>1.3×ULN (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.
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
- •Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age
- •Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 >1.3×ULN)
- •Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment
- •At least 12 months of follow up during 2nd line therapy
- •Signature of the informed consent to the study
排除标准
- •age ≤18 years
- •Pregnant and/or breastfeeding women
- •Patients unable to understand and sign the Informed Consent
结局指标
主要结局
Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN
时间窗: 12 months
Retrospective data on biochemical and clinical outcomes of patients affected by acromegaly treated with second-line medical therapy will be collected and analyzed. The patients will be stratified based on the therapeutic switch time (Time To Switch, TTS) \< 6 months, between 6 and 12 months and \> 12 months, from 1st generation SSA to the different second-line medical approaches (Pasireotide; Pegvisomant alone; Pegvisomant + first generation SSA combination). The impact of TTS on the biochemical and clinical control of illness will be analyzed.
次要结局
未报告次要终点
研究者
Andrea Giustina
Professor of Endocrinology
IRCCS San Raffaele