China Adrenal Disease Registry (CASE)

China Adrenal Disease Registry Study

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: shouyue SUN, MD; Phone Number: 18121263206; Email: ssy10926@rjh.com.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 71 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is an observational study. Participants enrolled in the study were diagnosed with adrenal associated diseases, including cushing syndrome, primary aldosteronism, primary hypoadrenalism, congenital adrenal hyperplasia and adrenal adenomas, incidentalomas, and carcinomas, pheochromocytoma. No gender restriction, between 16 and 75 years old.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): April 30, 2026
• Study Completion (Anticipated): April 30, 2026

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Endocrine Gland Neoplasms; Genetic Diseases, Inborn; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Metabolism, Inborn Errors; Neuroendocrine Tumors; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Paraganglioma; Adenoma; Hyperplasia; Hyperaldosteronism; Cushing Syndrome; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Pheochromocytoma; Adrenocortical Adenoma
• Other Study ID Numbers: Ruijin-adrenal01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No