China Pituitary Disease Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- remission and recurrence rate of pituitary surgery
研究概览
简要总结
Epidemiologic studies have revealed a tremendous increase in the prevalence of pituitary disease and related mortality worldwide. In order to meet all the challenges in the treatment of pituitary disease in China, CAPASITY was founded in 2020. The objective of CAPASITY is to launch a pituitary disease management model based on the Internet health information platform. It allows the application and evaluation of pituitary disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of pituitary disease, diagnosis, and treatment.
详细描述
In order to meet all the challenges in the diagnosis and treatment of pituitary diseases in China, CAPASITY was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CAPASITY is committed to creating an online and offline integrated solution for pituitary disease, and for the entire spectrum of pituitary disease, to achieve a more convenient and precise model of care for patients. aiming to establish a platform with diagnosis and treatment of pituitary disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.
Objective
- The purpose of the present study is to establish a multi-center nationwide prospective database of patients with pituitary adenomas to explore the epidemiology, biochemical, and clinical outcome related to pituitary tumors and its complications, as well as other pituitary disease.
- To collect cross-sectional data from patients seen and treated at each center so as to evaluate: the current status of care of patients with pituitary disease and its related complications, as well as other risk factors treatment strategies at multiple centers.
- To collect the prospective data of patients treated at each center in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of related clinical endpoints (including mortality), behavioral changes, as well as QoL.
Methods: After obtaining informed consent, patients will be invited and initiated with a comprehensive baseline evaluation at each CAPASITY center. Then patients will be followed by clinical/laboratory visits on according to individualized patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for hormones and imaging, as well as complications will be scheduled once a year.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 75 years
- •Patients diagnosed with pituitary adenomas, and other pituitary diseases
- •Pituitary adenomas resected by transsphenoidal surgery were identified by histological diagnoses.
- •Gender: males and females
- •Provide written informed consent
- •Satisfactory compliance
排除标准
- •Patients with significantly reduced life expectancy (less than 2 years)
- •With Drug abuse
- •With AIDS or syphilis or infectious diseases such as viral tuberculosis in active phase at enrollment
结局指标
主要结局
remission and recurrence rate of pituitary surgery
时间窗: through study completion, an average of 1 year
treatment outcome of pituitary adenoma. Results will be dichotomized as remission, persistence or recurrence.
percentage of functional pituitary adenoma
时间窗: through study completion, an average of 1 year
percentage of PRLoma, GHoma, ACTHoma, and etc
次要结局
- concentration of PRL(through study completion, an average of 1 year)
- concentration of ACTH(through study completion, an average of 1 year)
- concentration of GH(through study completion, an average of 1 year)
- concentration of IGF-1(through study completion, an average of 1 year)
- concentration of fT4(through study completion, an average of 1 year)
- concentration of TSH(through study completion, an average of 1 year)
- concentration of cortisol(through study completion, an average of 1 year)
- concentration of fT3(through study completion, an average of 1 year)
- pituitary MRI(through study completion, an average of 1 year)
- percentage of hypopituitarism(through study completion, an average of 1 year)
- percentage of diabetes insipidus, etc(through study completion, an average of 1 year)
研究者
Wang Weiqing
PhD, MD, Head of Department of Endocrine and Metabolism, Shanghai Jiaotong University School of Medicine, Chinese National Clinical Research Center for Endocrine and Metabolic Diseases (Shanghai)
Shanghai Jiao Tong University School of Medicine