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China Adrenal Disease Registry (CASE)

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ClinicalTrials.gov Identifier: NCT04890444
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Wang Weiqing, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: China Adrenal Disease Registry Study
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : April 30, 2026





Primary Outcome Measures :
  1. Percentage of adrenal diseases in China [ Time Frame: through study completion, an average of 1 year ]
  2. Number of participants with complication of adrenal diseases in China [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. concentration of aldosterone [ Time Frame: through study completion, an average of 1 year ]
  2. concentration of cortisol [ Time Frame: through study completion, an average of 1 year ]
  3. concentration of urine cortisol [ Time Frame: through study completion, an average of 1 year ]
  4. concentration of androstenedione [ Time Frame: through study completion, an average of 1 year ]
  5. concentration of adrenocorticotropic hormone [ Time Frame: through study completion, an average of 1 year ]
  6. concentration of 17-hydroxyprogesterone [ Time Frame: through study completion, an average of 1 year ]
  7. concentration of metanephrines [ Time Frame: through study completion, an average of 1 year ]
  8. changes in adrenal CT [ Time Frame: through study completion, an average of 1 year ]
  9. percentage of hypoadrenalism [ Time Frame: through study completion, an average of 1 year ]
  10. Mental health status [ Time Frame: 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.



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890444


Contacts
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Contact: shouyue SUN, MD 18121263206 ssy10926@rjh.com.cn

Locations
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China
Endocrinology Recruiting
Shanghai, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Wang Weiqing, Director, Head of Endocrinology, Principal Investigator, Clinical Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04890444    
Other Study ID Numbers: Ruijin-adrenal01
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Pheochromocytoma
Adrenocortical Adenoma
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Hyperaldosteronism
Cushing Syndrome
Hyperplasia
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Gonadal Disorders
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms