CASE: China Adrenal Disease Registry

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04890444

Collaborator

(none)

2,000

Enrollment

Location

58.9

Anticipated Duration (Months)

33.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Epidemiologic studies have revealed a tremendous increase in the prevalence of adrenal associated disease and related mortality worldwide. In order to meet all the therapeutic challenges in adrenal disease in China, CASE was founded in 2020. The objective of CASE is to launch an adrenal disease management model based on the Internet health information platform which allows the application and evaluation of adrenal disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of adrenal disease, diagnosis, and treatment.

Condition or Disease	Intervention/Treatment	Phase
Cushing Syndrome Aldosteronism Hypoadrenalism Congenital Adrenal Hyperplasia Adrenal Adenoma Adrenal Incidentaloma Adrenal Carcinoma Pheochromocytoma

Detailed Description

In order to meet all the challenges in the diagnosis and treatment of adrenal diseases in China, CASE was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CASE is committed to creating an online and offline integrated solution for adrenal disease, and for the entire spectrum of adrenal disease, to achieve a more convenient and precise model of care for patients, aiming to establish a platform with diagnosis and treatment of adrenal disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

China Adrenal Disease Registry Study

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2026

Anticipated Study Completion Date :

Apr 30, 2026

Outcome Measures

Primary Outcome Measures

Percentage of adrenal diseases in China [through study completion, an average of 1 year]
Number of participants with complication of adrenal diseases in China [through study completion, an average of 1 year]

Secondary Outcome Measures

concentration of aldosterone [through study completion, an average of 1 year]
concentration of cortisol [through study completion, an average of 1 year]
concentration of urine cortisol [through study completion, an average of 1 year]
concentration of androstenedione [through study completion, an average of 1 year]
concentration of adrenocorticotropic hormone [through study completion, an average of 1 year]
concentration of 17-hydroxyprogesterone [through study completion, an average of 1 year]
concentration of metanephrines [through study completion, an average of 1 year]
changes in adrenal CT [through study completion, an average of 1 year]
percentage of hypoadrenalism [through study completion, an average of 1 year]
Mental health status [through study completion, an average of 1 year]
The symptom checklist-90 will be used to evaluate the changes of participants' psychological state through study completion from 10 aspects, including somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, terror, paranoia, psychotic and others.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 75 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Age ≥ 16 years old and ≤ 75 years
Patients diagnosed with adrenal associated diseases, including cushing syndrome, primary aldosteronism, primary hypoadrenalism, congenital adrenal hyperplasia and adrenal adenomas, incidentalomas, and carcinomas, pheochromocytoma, etc.
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