Interstitial Lung Disease Associated

August 17, 2023 updated by: Peking Union Medical College Hospital
This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD spectrum share the same clinical manifestations and outcome with CTD feature disease spectrum.

Study Overview

Status

Completed

Conditions

Detailed Description

We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between January 2012 and December 2021.

  1. Baseline data collection:

    1. Baseline information at the time of initial diagnosis was obtained, and the following items were analyzed: demographic information (age, gender), clinical course, clinical symptoms and signs, laboratory findings [routine blood, erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP), rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests (PFTs), and chest HRCT scans.
    2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.
    3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists. The HRCT scans were analyzed for the following characteristics: ground-glass opacities, reticular patterns, honeycombing, traction bronchiectasis.
    4. Spirometry was performed according to standardized guidelines. PFTs results were expressed as percentages of the predicted values, thereby correcting for age, gender and bodyweight.
  2. Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to the time of patient's last visit or time of death, and the outcomes were defined as death from all causes.
  3. Outcome

Study Type

Observational

Enrollment (Actual)

1000

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Interstitial pneumonia based on clinical symptoms and radiologic features, with or without histopathologic results.

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

Exclusion Criteria:

  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: From baseline until the date of death from all cause, up to 5 years
death from all causes
From baseline until the date of death from all cause, 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

  • Principal Investigator: 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)

January 1, 2012

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-PCCM-ILD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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