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Retrospective Study for Diagnosis of Undetected IgG4 Related Diseases in Patients With High Serum IgG4 Levels.

NCT02229448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2017-11-17

No results posted yet for this study

Summary

Immunoglobulin G4-related disease (IgG4-RD) is an increasingly recognized syndrome of unknown etiology comprised of a collection of disorders that share specific pathologic, serologic, and clinical features.

Histopathological analysis of biopsy specimens remains the cornerstone in the diagnosis of IgG4- related disease. Elevated concentrations of IgG4 in tissue and serum are helpful in diagnosing IgG4-related disease, but neither one is a specific diagnostic marker. Correlation with specific histopathological findings is essential, regardless of the serum IgG4 concentration, the number of IgG4-positive plasma cells in tissue, or the ratio of IgG4 to IgG in tissue. Misdiagnoses of IgG4-related disease are increasingly common because of excessive emphasis on moderate elevations of serum IgG4 concentration and overreliance on the finding of IgG4-positive plasma cells in tissue.

Conditions

  • Undiagnosed IgG4 Related Diseases

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Yair Levy, MD · Meir Medical Center

  • Shalabi Khaled · Meir Medical Center

  • Evgeny Edelshtein, MD · Meir Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229448 on ClinicalTrials.gov