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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04890444
Other study ID # Ruijin-adrenal01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date April 30, 2026

Study information

Verified date January 2022
Source Shanghai Jiao Tong University School of Medicine
Contact shouyue SUN, MD
Phone 18121263206
Email ssy10926@rjh.com.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers
Gender All
Age group 16 Years to 75 Years
Eligibility 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


Locations

Country Name City State
China Endocrinology Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of adrenal diseases in China through study completion, an average of 1 year
Primary Number of participants with complication of adrenal diseases in China through study completion, an average of 1 year
Secondary concentration of aldosterone through study completion, an average of 1 year
Secondary concentration of cortisol through study completion, an average of 1 year
Secondary concentration of urine cortisol through study completion, an average of 1 year
Secondary concentration of androstenedione through study completion, an average of 1 year
Secondary concentration of adrenocorticotropic hormone through study completion, an average of 1 year
Secondary concentration of 17-hydroxyprogesterone through study completion, an average of 1 year
Secondary concentration of metanephrines through study completion, an average of 1 year
Secondary changes in adrenal CT through study completion, an average of 1 year
Secondary percentage of hypoadrenalism through study completion, an average of 1 year
Secondary Mental health status 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. through study completion, an average of 1 year
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