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Specific Autoantibody Testing in Patients With Interstitial Lung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600352
First Posted: May 17, 2012
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Singapore General Hospital
  Purpose
The purpose of this study is to evaluate the clinical utility of specific autoantibody testing in unmasking an underlying connective tissue disorder in patients who present with interstitial lung disease and found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease.

Condition
Interstitial Lung Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: To Evaluate the Clinical Utility of Specific Autoantibody Testing in Patients With Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Clinical utility of specific autoantibody testing [ Time Frame: 3 months ]
    Utility of specific autoantibodies to diagnose underlying connective tissue disease in patients presenting with interstitial lung disease who do not demonstrate overt clinical manifestations of connective tissue disease and our current available autoantibody screen does not detect all potential autoantibodies present.


Biospecimen Retention:   Samples Without DNA
Blood

Enrollment: 20
Study Start Date: May 2012
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed Description:
It has been well established that patients with connective tissue disease associated interstitial lung disease respond better to immunosuppressive therapy, and have a better outcome compared to patients with idiopathic interstitial pneumonias. This makes it imperative to identify this group of patients for management and prognostication. Unfortunately some of these patients do not demonstrate overt clinical manifestations of connective tissue disease and our current available autoantibody screen does not detect all potential autoantibodies present. We would like to test for specific autoantibodies in this group of patients to evaluate its clinical utility in identifying covert connective tissue diseases associated with interstitial lung disease.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with weak positive ANA (1:400 titre) and no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease.
Criteria

Inclusion Criteria:

  1. Patients 21 years old and older
  2. Patients with interstitial lung disease who have been found to have weak positive ANA (1:400 titre) with no overt connective tissue disease manifestations OR borderline/negative ANA with some clinical suggestion of connective tissue disease will be offered specific autoantibody testing

Exclusion Criteria:

  1. Inability and unwillingness to sign informed consent
  2. Patients who are pregnant or have underlying malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600352


Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Su Ying Low, BMBCh Singapore General Hospital
  More Information

Publications:
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01600352     History of Changes
Other Study ID Numbers: 2012/245/Cautoantibodies
First Submitted: May 15, 2012
First Posted: May 17, 2012
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Singapore General Hospital:
interstitial lung disease
idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs