Cushing SyndromeCASENCT04890444
China Adrenal Disease Registry
An observational study of Cushing Syndrome and Aldosteronism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Cushing Syndrome, Aldosteronism, Hypoadrenalism
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Age ≥ 16 years old and ≤ 75 years
- Patients diagnosed with adrenal associated diseases, including cushing syndrome, primary aldosteronism, primary hypoadrenalism, congenital adrenal hyperplasia and adrenal adenomas, incidentalomas, and carcinomas, pheochromocytoma, etc.
- Provide written informed consent
- Satisfactory compliance
Who cannot join
- Patients with significantly reduced life expectancy (less than 2 years)
- With Drug abuse
- With AIDS or syphilis or infectious diseases such as viral tuberculosis in active phase at enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cushing Syndrome, Aldosteronism, Hypoadrenalism, Congenital Adrenal Hyperplasia, Adrenal Adenoma, Adrenal Incidentaloma
- Medical subject headings
- Cushing Syndrome, Hyperaldosteronism, Adrenal Insufficiency, Adrenal Hyperplasia, Congenital, ACTH Syndrome, Ectopic, Adrenal incidentaloma, Adrenal Cortex Neoplasms, Pheochromocytoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adrenal diseases in China
Measured: through study completion, an average of 1 year
Number of participants with complication of adrenal diseases in China
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
concentration of aldosterone
Measured: through study completion, an average of 1 year
concentration of cortisol
Measured: through study completion, an average of 1 year
concentration of urine cortisol
Measured: through study completion, an average of 1 year
concentration of androstenedione
Measured: through study completion, an average of 1 year
concentration of adrenocorticotropic hormone
Measured: through study completion, an average of 1 year
concentration of 17-hydroxyprogesterone
Measured: through study completion, an average of 1 year
concentration of metanephrines
Measured: through study completion, an average of 1 year
changes in adrenal CT
Measured: through study completion, an average of 1 year
percentage of hypoadrenalism
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jun 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890444
- Sponsor's protocol ID
- Ruijin-adrenal01
- Acronym
- CASE
- Status last verified
- Jan 2022
- First submitted
- 7 May 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Adrenal Disease Registry Study
- ClinicalTrials.gov ID
- NCT04890444
- Acronym / sponsor ID
- CASE / Ruijin-adrenal01
- Conditions
- Cushing Syndrome, Aldosteronism, Hypoadrenalism, Congenital Adrenal Hyperplasia, Adrenal Adenoma, Adrenal Incidentaloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 16 years old and ≤ 75 years
- Patients diagnosed with adrenal associated diseases, including cushing syndrome, primary aldosteronism, primary hypoadrenalism, congenital adrenal hyperplasia and adrenal adenomas, incidentalomas, and carcinomas, pheochromocytoma, etc.
- Provide written informed consent
- Satisfactory compliance
Key exclusion criteria (3 listed)
- Patients with significantly reduced life expectancy (less than 2 years)
- With Drug abuse
- With AIDS or syphilis or infectious diseases such as viral tuberculosis in active phase at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of adrenal diseases in China
Time frame: through study completion, an average of 1 year
Number of participants with complication of adrenal diseases in China
Time frame: through study completion, an average of 1 year
10 secondary outcomes
concentration of aldosterone
Time frame: through study completion, an average of 1 year
concentration of cortisol
Time frame: through study completion, an average of 1 year
concentration of urine cortisol
Time frame: through study completion, an average of 1 year
concentration of androstenedione
Time frame: through study completion, an average of 1 year
concentration of adrenocorticotropic hormone
Time frame: through study completion, an average of 1 year
concentration of 17-hydroxyprogesterone
Time frame: through study completion, an average of 1 year
concentration of metanephrines
Time frame: through study completion, an average of 1 year
changes in adrenal CT
Time frame: through study completion, an average of 1 year
percentage of hypoadrenalism
Time frame: through study completion, an average of 1 year
Mental health status
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Syndrome and Aldosteronism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shouyue SUN, MD (18121263206, ssy10926@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adrenal diseases in China (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.