China Adrenal Disease Registry

Recruiting

• Conditions: Congenital Adrenal Hyperplasia; Aldosteronism; Hypoadrenalism; Adrenal Adenoma; Adrenal Incidentaloma; Pheochromocytoma; Cushing Syndrome; Adrenal Carcinoma

• Registration Number: NCT04890444
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

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 Timeline

• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-06-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-14
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Age ≥ 16 years old and ≤ 75 years
2. Patients diagnosed with adrenal associated diseases, including cushing syndrome, primary aldosteronism, primary hypoadrenalism, congenital adrenal hyperplasia and adrenal adenomas, incidentalomas, and carcinomas, pheochromocytoma, etc.
3. Provide written informed consent
4. Satisfactory compliance

Exclusion Criteria

1. Patients with significantly reduced life expectancy (less than 2 years)
2. With Drug abuse
3. With AIDS or syphilis or infectious diseases such as viral tuberculosis in active phase at enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 cortisol	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
concentration of metanephrines	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.
concentration of aldosterone	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

Trial Locations

Locations (1)

Endocrinology; 🇨🇳 Shanghai, China