Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.

May 28, 2020 updated by: Peking Union Medical College Hospital

Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.

The purpose of this study is to investigate the clinical features and long-term outcome of anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated ANCA-positive idiopathic interstitial pneumonia.

Study Overview

Status

Completed

Conditions

Detailed Description

ILD patients with serum ANCA-positivity were enrolled in this study.

  1. Baseline data collection:

    1. Demographics information (age, gender)
    2. Clinical course
    3. Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing fingers, mechanics hand)
    4. Laboratory findings (blood and urine routine, liver and renal function tests, erythrocyte sedimentation rate, C reactive protein)
    5. Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP), Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)
    6. Systemic manifestation if diagnosed as systemic vasculitis
    7. Pulmonary function tests (ventilation and diffusion capacity test)
    8. Chest high-resolution computed tomography (HRCT)
  2. Treatment: treatment will be given according to the experience of each pulmonologist.

  3. Follow-up:

    1. Patients were followed up at least once a year and basic laboratory tests, serologic autoantibodies, pulmonary function test and chest HRCT were evaluated routinely
    2. Follow-up end point was April 2019.
  4. Outcome

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Interstitial lung disease patients with anti-neutrophil cytoplasmic antibody.

Description

Inclusion Criteria:

  • Males and females
  • Aged from 18 to 85 years with informed consent
  • Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results
  • Have available ANCA testing results during the first visit and follow-up period

Exclusion Criteria:

  • Connective tissue disease associated ILD
  • ILD induced by drug, environment, or occupational exposure
  • Hypersensitivity pneumonitis and sarcoidosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death from all cause
Time Frame: From baseline until the date of death from all cause, up to 5 years
Death from all cause
From baseline until the date of death from all cause, up to 5 years
Number of patients who underwent lung transplantation
Time Frame: From baseline until the date of transplantation, up to 5 years
Number of patients who underwent lung transplantation
From baseline until the date of transplantation, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Juhong Shi, M.D, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-ANCA-positive ILD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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