Clinical trial NCT04890444: China Adrenal Disease Registry
Official title: China Adrenal Disease Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cushing Syndrome
Aldosteronism
Hypoadrenalism
Congenital Adrenal Hyperplasia
Adrenal Adenoma
Adrenal Incidentaloma
Adrenal Carcinoma
Pheochromocytoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of adrenal diseases in China
timeFrame: through study completion, an average of 1 year
measure: Number of participants with complication of adrenal diseases in China
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: concentration of aldosterone
timeFrame: through study completion, an average of 1 year
measure: concentration of cortisol
timeFrame: through study completion, an average of 1 year
measure: concentration of urine cortisol
timeFrame: through study completion, an average of 1 year
measure: concentration of androstenedione
timeFrame: through study completion, an average of 1 year
measure: concentration of adrenocorticotropic hormone
timeFrame: through study completion, an average of 1 year
measure: concentration of 17-hydroxyprogesterone
timeFrame: through study completion, an average of 1 year
measure: concentration of metanephrines
timeFrame: through study completion, an average of 1 year
measure: changes in adrenal CT
timeFrame: through study completion, an average of 1 year
measure: percentage of hypoadrenalism
timeFrame: through study completion, an average of 1 year
measure: Mental health status
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Endocrinology
Study officials:
References: