Clinical trial NCT04713293: China Pituitary Disease Registry (CAPASITY)
Official title: China Pituitary Disease Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pituitary Disease
Keywords: Pituitary Disease
Pituitary Adenoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pituitary disease

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.

Eligibility 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

Primary outcomes:
measure: percentage of functional pituitary adenoma
timeFrame: through study completion, an average of 1 year
measure: remission and recurrence rate of pituitary surgery
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: concentration of GH
timeFrame: through study completion, an average of 1 year
measure: concentration of IGF-1
timeFrame: through study completion, an average of 1 year
measure: concentration of PRL
timeFrame: through study completion, an average of 1 year
measure: concentration of ACTH
timeFrame: through study completion, an average of 1 year
measure: concentration of cortisol
timeFrame: through study completion, an average of 1 year
measure: concentration of fT3
timeFrame: through study completion, an average of 1 year
measure: concentration of fT4
timeFrame: through study completion, an average of 1 year
measure: concentration of TSH
timeFrame: through study completion, an average of 1 year
measure: pituitary MRI
timeFrame: through study completion, an average of 1 year
measure: percentage of hypopituitarism
timeFrame: through study completion, an average of 1 year
measure: percentage of diabetes insipidus, etc
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: National Metabolic Management center
state: Shanghai
Study officials:
affiliation: National Metabolic Management center (Shanghai)
name: Weiqing Wang, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: