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NCT Number: NCT03023371

National Registry of IgG4-RD in China

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Organ involvements of Chinese IgG4-RD patients

    Time frame: 5 years

    To calculate the percentage of organ involvements in at least 900 patients.

Secondary outcomes

  1. Response rate of glucocorticoids and immunosuppressants on IgG4-RD in China

    Time frame: 5 years

  2. Relapse rate of IgG4-RD patients in China

    Time frame: 5 years

  3. The correlation between baseline disease activities and relapse rate.

    Time frame: 5 years

  4. The incidence rate of tumor in IgG4 related disease patients in China.

    Time frame: 5 years

  5. Ten year survival rate of patients with IgG4 related disease in China.

    Time frame: 10 years

  6. The imaging features of involved organs.

    Time frame: 3 years

  7. The sensitivity and specificity of IgG4 positive plasma cells in pathological diagnosis of IgG4 related disease.

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Wen Zhang

CONTACT

[email protected]

Yunyun Fei

CONTACT

[email protected]

+8613681125226

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2017
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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