Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04713293
Status:
RECRUITING
Last Update Posted:
2021-01-19
First Post:
2020-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Pituitary Disease Registry (CAPASITY)
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Study Overview
Official Title:
China Pituitary Disease Registry Study
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: