IgG4-Related DiseaseNCT03023371
National Registry of IgG4-RD in China
An observational study of IgG4-Related Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China. Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled from multi-centers around China. A online database system has been established. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IgG4-Related Disease
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: IgG4-RD patients around China
Who may be able to join
- Conforming to the diagnostic criteria of IgG4-RD (2011);
Who cannot join
- Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wen Zhang contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Yunyun Fei, +8613681125226, feiyunyun2013@hotmail.com
Wen Zhang, zhangwen91@sina.com
About this study
The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China.
Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled from multi-centers around China. A online database system has been established.
Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IgG4-RD patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.
Read the detailed description
This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients will be recruited from allover the China. Inclusion criteria: patients with definite, probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded.
The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.
This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will signe informed consent.
Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.
Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD patients. The secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.
- Conditions
- IgG4-Related Disease
- Keywords
- Registry; cohort study; IgG4-related disease
- Medical subject headings
- Immunoglobulin G4-Related Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ involvements of Chinese IgG4-RD patients
To calculate the percentage of organ involvements in at least 900 patients.
Measured: 5 years
Secondary outcomes (7)
Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
Measured: 5 years
Relapse rate of IgG4-RD patients in China
Measured: 5 years
The correlation between baseline disease activities and relapse rate.
Measured: 5 years
The incidence rate of tumor in IgG4 related disease patients in China.
Measured: 5 years
Ten year survival rate of patients with IgG4 related disease in China.
Measured: 10 years
The imaging features of involved organs.
Measured: 3 years
The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4-Related DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 900 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Zhang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023371
- Sponsor's protocol ID
- IgG4-RD Group in China
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of IgG4-RD in China
- ClinicalTrials.gov ID
- NCT03023371
- Acronym / sponsor ID
- IgG4-RD Group in China
- Conditions
- IgG4-Related Disease
- Keywords
- Registry; cohort study; IgG4-related disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
The aim of this study is to establish a nation-wide cohort study of IgG4-related disease (IgG4-RD) in China.
Methods: All the patients fulfilling diagnostic criteria of IgG4-RD (2011) would be enrolled from multi-centers around China. A online database system has been established.
Endpoints: The primary endpoint is to investigate the clinical manifestations of Chinese IgG4-RD patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.
Detailed description
This is a multicenter registry study of IgG4-RD patients. Newly diagnosed IgG4-RD patients will be recruited from allover the China. Inclusion criteria: patients with definite, probable, or possible IgG4-RD according to the 2011 comprehensive diagnostic criteria for IgG4-RD will be recruited. Exclusion criteria: patients with malignancy or other autoimmune diseases are excluded.
The data will be uploaded through the platform of Chinese Rheumatology Information Platform. Demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded.
This study was approved by the Medical Ethics Committee of PUMCH (Beijing, China). All patients will signe informed consent.
Statistical Analysis: All parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. All statistical analyses will be performed by SPSS.
Endpoints: The primary endpoint is to investigate the organ involvements of Chinese IgG4-RD patients. The secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IgG4-RD patients around China
Key inclusion criteria (1 listed)
- Conforming to the diagnostic criteria of IgG4-RD (2011);
Key exclusion criteria (1 listed)
- Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.
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
Organ involvements of Chinese IgG4-RD patients
Time frame: 5 years
To calculate the percentage of organ involvements in at least 900 patients.
7 secondary outcomes
Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China
Time frame: 5 years
Relapse rate of IgG4-RD patients in China
Time frame: 5 years
The correlation between baseline disease activities and relapse rate.
Time frame: 5 years
The incidence rate of tumor in IgG4 related disease patients in China.
Time frame: 5 years
Ten year survival rate of patients with IgG4 related disease in China.
Time frame: 10 years
The imaging features of involved organs.
Time frame: 3 years
The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: Yes
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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.
Wen Zhang contact
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 IgG4-Related Disease, run by Peking Union Medical College Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jan 2017. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunyun Fei (+8613681125226, feiyunyun2013@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ involvements of Chinese IgG4-RD patients (time frame: 5 years). 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 24 Jan 2017.