China Pituitary Disease Registry (CAPASITY)

January 14, 2021 updated by: Wang Weiqing, Shanghai Jiao Tong University School of Medicine

China Pituitary Disease Registry Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Weiqing Wang, MD, PHD
  • Phone Number: 671817 008621-64370045
  • Email: wqingw61@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • National Metabolic Management center
        • Contact:
          • Weiqing Wang, Professor
          • Phone Number: 671817 008621-64370045
          • Email: wqingw61@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pituitary disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of functional pituitary adenoma
Time Frame: through study completion, an average of 1 year
percentage of PRLoma, GHoma, ACTHoma, and etc
through study completion, an average of 1 year
remission and recurrence rate of pituitary surgery
Time Frame: through study completion, an average of 1 year
treatment outcome of pituitary adenoma. Results will be dichotomized as remission, persistence or recurrence.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of GH
Time Frame: through study completion, an average of 1 year
changes in GH
through study completion, an average of 1 year
concentration of IGF-1
Time Frame: through study completion, an average of 1 year
changes in IGF-1
through study completion, an average of 1 year
concentration of PRL
Time Frame: through study completion, an average of 1 year
changes in PRL
through study completion, an average of 1 year
concentration of ACTH
Time Frame: through study completion, an average of 1 year
changes in ACTH
through study completion, an average of 1 year
concentration of cortisol
Time Frame: through study completion, an average of 1 year
changes in cortisol
through study completion, an average of 1 year
concentration of fT3
Time Frame: through study completion, an average of 1 year
changes in fT3
through study completion, an average of 1 year
concentration of fT4
Time Frame: through study completion, an average of 1 year
changes in fT4
through study completion, an average of 1 year
concentration of TSH
Time Frame: through study completion, an average of 1 year
changes in TSH
through study completion, an average of 1 year
pituitary MRI
Time Frame: through study completion, an average of 1 year
changes in MRI of sellar area
through study completion, an average of 1 year
percentage of hypopituitarism
Time Frame: through study completion, an average of 1 year
percentage of hypopituitarism
through study completion, an average of 1 year
percentage of diabetes insipidus, etc
Time Frame: through study completion, an average of 1 year
percentage of diabetes insipidus, etc
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Weiqing Wang, MD, PHD, National Metabolic Management center (Shanghai)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2020

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0/20200606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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