Pituitary DiseaseNCT04713293
China Pituitary Disease Registry (CAPASITY)
An observational study of Pituitary Disease, 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 pituitary disease and related mortality worldwide. In order to meet all the challenges in the treatment of pituitary disease in China, CAPASITY was founded in 2020. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Pituitary Disease
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2020to 31 Dec 2025
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pituitary disease
Who may be able to join
- Age ≥ 18 years old and ≤ 75 years
- Patients diagnosed with pituitary adenomas, and other pituitary diseases
- Pituitary adenomas resected by transsphenoidal surgery were identified by histological diagnoses.
- Gender: males and females
- 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.
China1 site, 1 recruiting
- Recruiting
National Metabolic Management center
Shanghai, Shanghai Municipality, 200025
Weiqing Wang, Professor, 008621-64370045 ext. 671817, wqingw61@163.com
About this study
Official title: China Pituitary Disease Registry Study
Epidemiologic studies have revealed a tremendous increase in the prevalence of pituitary disease and related mortality worldwide. In order to meet all the challenges in the treatment of pituitary disease in China, CAPASITY was founded in 2020. The objective of CAPASITY is to launch a pituitary disease management model based on the Internet health information platform. It allows the application and evaluation of pituitary disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of pituitary disease, diagnosis, and treatment.
Read the detailed description
In order to meet all the challenges in the diagnosis and treatment of pituitary diseases in China, CAPASITY was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CAPASITY is committed to creating an online and offline integrated solution for pituitary disease, and for the entire spectrum of pituitary disease, to achieve a more convenient and precise model of care for patients. aiming to establish a platform with diagnosis and treatment of pituitary disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.
Objective:
- The purpose of the present study is to establish a multi-center nationwide prospective database of patients with pituitary adenomas to explore the epidemiology, biochemical, and clinical outcome related to pituitary tumors and its complications, as well as other pituitary disease.
- To collect cross-sectional data from patients seen and treated at each center so as to evaluate: the current status of care of patients with pituitary disease and its related complications, as well as other risk factors treatment strategies at multiple centers.
- To collect the prospective data of patients treated at each center in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of related clinical endpoints (including mortality), behavioral changes, as well as QoL.
Methods: After obtaining informed consent, patients will be invited and initiated with a comprehensive baseline evaluation at each CAPASITY center. Then patients will be followed by clinical/laboratory visits on according to individualized patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for hormones and imaging, as well as complications will be scheduled once a year.
- Conditions
- Pituitary Disease
- Keywords
- Pituitary Disease, Pituitary Adenoma
- Medical subject headings
- Pituitary Diseases, Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of functional pituitary adenoma
percentage of PRLoma, GHoma, ACTHoma, and etc
Measured: through study completion, an average of 1 year
remission and recurrence rate of pituitary surgery
treatment outcome of pituitary adenoma. Results will be dichotomized as remission, persistence or recurrence.
Measured: through study completion, an average of 1 year
Secondary outcomes (11)
concentration of GH
changes in GH
Measured: through study completion, an average of 1 year
concentration of IGF-1
changes in IGF-1
Measured: through study completion, an average of 1 year
concentration of PRL
changes in PRL
Measured: through study completion, an average of 1 year
concentration of ACTH
changes in ACTH
Measured: through study completion, an average of 1 year
concentration of cortisol
changes in cortisol
Measured: through study completion, an average of 1 year
concentration of fT3
changes in fT3
Measured: through study completion, an average of 1 year
concentration of fT4
changes in fT4
Measured: through study completion, an average of 1 year
concentration of TSH
changes in TSH
Measured: through study completion, an average of 1 year
pituitary MRI
changes in MRI of sellar area
Measured: through study completion, an average of 1 year
percentage of hypopituitarism
percentage of hypopituitarism
Measured: through study completion, an average of 1 year
percentage of diabetes insipidus, etc
percentage of diabetes insipidus, etc
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 posted19 Jan 2021
- Study start26 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary DiseaseStudies 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
- Investigators
- Weiqing Wang, MD, PHD, Principal investigator, National Metabolic Management center (Shanghai)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713293
- Sponsor's protocol ID
- 1.0/20200606
- Status last verified
- Jan 2021
- First submitted
- 31 Dec 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Pituitary Disease Registry Study
- ClinicalTrials.gov ID
- NCT04713293
- Acronym / sponsor ID
- 1.0/20200606
- Conditions
- Pituitary Disease
- Keywords
- Pituitary Disease, Pituitary Adenoma
- 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
- 26 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 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 pituitary disease and related mortality worldwide. In order to meet all the challenges in the treatment of pituitary disease in China, CAPASITY was founded in 2020. The objective of CAPASITY is to launch a pituitary disease management model based on the Internet health information platform. It allows the application and evaluation of pituitary disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of pituitary disease, diagnosis, and treatment.
Detailed description
In order to meet all the challenges in the diagnosis and treatment of pituitary diseases in China, CAPASITY was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CAPASITY is committed to creating an online and offline integrated solution for pituitary disease, and for the entire spectrum of pituitary disease, to achieve a more convenient and precise model of care for patients. aiming to establish a platform with diagnosis and treatment of pituitary disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.
Objective:
- The purpose of the present study is to establish a multi-center nationwide prospective database of patients with pituitary adenomas to explore the epidemiology, biochemical, and clinical outcome related to pituitary tumors and its complications, as well as other pituitary disease.
- To collect cross-sectional data from patients seen and treated at each center so as to evaluate: the current status of care of patients with pituitary disease and its related complications, as well as other risk factors treatment strategies at multiple centers.
- To collect the prospective data of patients treated at each center in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of related clinical endpoints (including mortality), behavioral changes, as well as QoL.
Methods: After obtaining informed consent, patients will be invited and initiated with a comprehensive baseline evaluation at each CAPASITY center. Then patients will be followed by clinical/laboratory visits on according to individualized patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for hormones and imaging, as well as complications will be scheduled once a year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pituitary disease
Key inclusion criteria (6 listed)
- Age ≥ 18 years old and ≤ 75 years
- Patients diagnosed with pituitary adenomas, and other pituitary diseases
- Pituitary adenomas resected by transsphenoidal surgery were identified by histological diagnoses.
- Gender: males and females
- Provide written informed consent
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 functional pituitary adenoma
Time frame: through study completion, an average of 1 year
percentage of PRLoma, GHoma, ACTHoma, and etc
remission and recurrence rate of pituitary surgery
Time frame: through study completion, an average of 1 year
treatment outcome of pituitary adenoma. Results will be dichotomized as remission, persistence or recurrence.
11 secondary outcomes
concentration of GH
Time frame: through study completion, an average of 1 year
concentration of IGF-1
Time frame: through study completion, an average of 1 year
concentration of PRL
Time frame: through study completion, an average of 1 year
concentration of ACTH
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 fT3
Time frame: through study completion, an average of 1 year
concentration of fT4
Time frame: through study completion, an average of 1 year
concentration of TSH
Time frame: through study completion, an average of 1 year
pituitary MRI
Time frame: through study completion, an average of 1 year
percentage of hypopituitarism
Time frame: through study completion, an average of 1 year
percentage of diabetes insipidus, etc
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 19 Jan 2021.
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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.
Weiqing Wang, MD, PHD principal investigator
National Metabolic Management center (Shanghai)
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 Pituitary Disease, 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 6 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 19 Jan 2021. 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 Weiqing Wang, MD, PHD (008621-64370045 ext. 671817, wqingw61@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of functional pituitary adenoma (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 19 Jan 2021.