ClinicalTrials.gov record NCT01670695
A Prospective Cohort Study of IgG4RD in China
Cohort Study of Patients With IgG4-Related Disease
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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 is a prospective cohort study of adults with newly diagnosed IgG4-related disease. It collects clinical, laboratory and imaging information while patients receive standard care and are followed for at least 6 months. The study seeks to describe disease course and measure clinical response.
What it is studying. The study is testing how IgG4-related disease presents and progresses, and how patients respond to standard treatments, using measures such as the IgG4-RD Responder Index, organ/site scores, and serum IgG4 level.
What the researchers hope to learn. To describe clinical presentations, laboratory and imaging findings, and the natural history of IgG4-related disease; and to evaluate clinical response measures (IgG4-RD Responder Index, organ/site scores, serum IgG4) to standard care.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Males and females
- Age 18-75 years old with informed consent
- Patients with IgG4-RD:
- swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
- elevated serum IgG4 (>1.35 g/L)
- histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
- exclusion of other diseases.
Exclusion criteria
- Females planning to bear a child recently or with childbearing potential
- Concurrent severe and/or uncontrolled and/or unstable diseases
- Patient with malignancy
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration. In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.
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.
Participants receive standard care for IgG4‑RD and are followed for at least six months. They will have clinical evaluations, blood tests including serum IgG4 level, and imaging studies; tissue biopsy/histopathology may be performed if done as part of clinical care. Disease activity will be measured using the IgG4‑RD Responder Index (including organ/site scores and serum IgG4) at about six months.
How the study is structured. A prospective observational cohort: participants receive usual medical care while the study team collects clinical data, lab results, and imaging and follows them over time (minimum follow-up 6 months). 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
Important dates
- Study start
- January 2012
- Primary completion
- January 2032 (estimated)
- Study completion
- January 2032 (estimated)
- Target enrollment
- 1000 participants (estimated)
- Last updated on registry
- Apr 11, 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.
- Hua Chen, MD 📞 86-10-69158797 ✉ chen77hua@gmail.com
Participating sites (1)
- Deptment of Rheumatology, Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, 100032 · China
- Wen Zhang, MD · 86-10-69158795 · zhangwen91@sina.com
- Hua Chen, MD · 86-10-69158797 · chen77hua@gmail.com
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.
- 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.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- 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.
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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