NCT04713293

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

5.4 years

First QC Date

December 31, 2020

Last Update Submit

January 14, 2021

Conditions

Keywords

Pituitary DiseasePituitary Adenoma

Outcome Measures

Primary Outcomes (2)

  • percentage of functional pituitary adenoma

    percentage of PRLoma, GHoma, ACTHoma, and etc

    through study completion, an average of 1 year

  • 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 Outcomes (11)

  • concentration of GH

    through study completion, an average of 1 year

  • concentration of IGF-1

    through study completion, an average of 1 year

  • concentration of PRL

    through study completion, an average of 1 year

  • concentration of ACTH

    through study completion, an average of 1 year

  • concentration of cortisol

    through study completion, an average of 1 year

  • +6 more secondary outcomes

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pituitary disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Metabolic Management center

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Pituitary DiseasesPituitary Neoplasms

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System Neoplasms

Study Officials

  • Weiqing Wang, MD, PHD

    National Metabolic Management center (Shanghai)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiqing Wang, MD, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD, Head of Department of Endocrine and Metabolism, Shanghai Jiaotong University School of Medicine, Chinese National Clinical Research Center for Endocrine and Metabolic Diseases (Shanghai)

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 19, 2021

Study Start

July 26, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations