China Pituitary Disease Registry (CAPASITY)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	14 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04713293
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Jiao Tong University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Weiqing Wang, MD, PHD
Principal Investigator Affiliation	National Metabolic Management center (Shanghai)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Disease

Additional Details

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.

Contact a Trial Team

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International Sites

National Metabolic Management center, Shanghai 1796236, Shanghai Municipality 1796231, China

Status

Recruiting

Address

National Metabolic Management center

Shanghai 1796236, Shanghai Municipality 1796231, 200025

Site Contact

Weiqing Wang, Professor

[email protected]

008621-64370045 #671817

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