ClinicalTrials.gov record NCT03023371

National Registry of IgG4-RD in China

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

National Registry of IgG4-RD in China

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jan 24, 2017, about 9 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This multicenter, prospective registry will collect clinical and laboratory data on people in China diagnosed with IgG4-related disease using the 2011 diagnostic criteria. Newly diagnosed patients meeting those criteria are eligible; patients with malignancy, other autoimmune diseases, or conditions that mimic IgG4-RD (for example tumors, vasculitis, sarcoidosis) are excluded. Data are entered into an online database and participants may be followed for up to 10 years. The registry aims to describe organ involvement, treatments, and outcomes in Chinese IgG4-RD patients.

What it is studying. It seeks to describe how IgG4-related disease appears and progresses in Chinese patients — which organs are affected, typical lab, imaging and pathology findings, treatments given, and patient outcomes.

What the researchers hope to learn. Scientific goals include measuring how often different organs are involved (primary endpoint), describing demographic and laboratory features, documenting imaging and pathological findings, recording treatments and their response rates, estimating relapse and tumor incidence rates, and reporting long-term outcomes such as 10-year survival; the registry also aims to assess diagnostic performance of IgG4-positive plasma cells in pathology.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Conforming to the diagnostic criteria of IgG4-RD (2011);

Exclusion criteria

  • Excluding other mimicing IgG4-RD, including tumors, vasculitis and sarcoidosis.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Study staff will record your medical and test information in an online registry: demographics, symptoms, disease duration, allergy history, physical exam findings, organ involvement, laboratory, imaging and pathology results, treatments and side effects. You will be asked to sign informed consent. Participants' data will be followed over time for outcomes listed in the registry (for example treatment response, relapse, imaging features, tumor incidence and survival) with data collection planned up to 10 years. The registry record does not specify any additional study-only invasive procedures beyond collection of clinical and test information from routine care.

How the study is structured. A multicenter, prospective observational registry (cohort). Treating teams enter standardized clinical, laboratory, imaging, pathology, treatment and outcome data into an online platform. Participants are followed over time (target duration up to 10 years). No experimental treatments are assigned by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on IgG4-related disease

Clinical trials32 trials listed for IgG4-related diseaseEvery trial the registry lists for IgG4-related disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in IgG4-related disease researchLatest monthly update: September 2026. Includes: Relapse prevention trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
December 2016
Primary completion
December 2026 (estimated)
Study completion
December 2026 (estimated)
Target enrollment
900 participants (estimated)
Last updated on registry
Jan 24, 2017
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking Union Medical College Hospital
Principal investigator
Wen Zhang, Professor
Peking Union Medical College Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

cohort study
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
Endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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