China Pituitary Disease Registry (CAPASITY)

Pituitary Disease Clinical Trial

Official title:

China Pituitary Disease Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04713293
• Other study ID #: 1.0/20200606
• Status: Recruiting
• Start date: July 26, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Weiqing Wang, MD, PHD
• Phone: 008621-64370045
• Email: wqingw61[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pituitary Disease
• Pituitary Diseases

Locations

Country	Name	City	State
China	National Metabolic Management center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of functional pituitary adenoma	percentage of PRLoma, GHoma, ACTHoma, and etc	through study completion, an average of 1 year
Primary	remission and recurrence rate of pituitary surgery	treatment outcome of pituitary adenoma. Results will be dichotomized as remission, persistence or recurrence.	through study completion, an average of 1 year
Secondary	concentration of GH	changes in GH	through study completion, an average of 1 year
Secondary	concentration of IGF-1	changes in IGF-1	through study completion, an average of 1 year
Secondary	concentration of PRL	changes in PRL	through study completion, an average of 1 year
Secondary	concentration of ACTH	changes in ACTH	through study completion, an average of 1 year
Secondary	concentration of cortisol	changes in cortisol	through study completion, an average of 1 year
Secondary	concentration of fT3	changes in fT3	through study completion, an average of 1 year
Secondary	concentration of fT4	changes in fT4	through study completion, an average of 1 year
Secondary	concentration of TSH	changes in TSH	through study completion, an average of 1 year
Secondary	pituitary MRI	changes in MRI of sellar area	through study completion, an average of 1 year
Secondary	percentage of hypopituitarism	percentage of hypopituitarism	through study completion, an average of 1 year
Secondary	percentage of diabetes insipidus, etc	percentage of diabetes insipidus, etc	through study completion, an average of 1 year