Specific Autoantibody Testing in Patients With Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

To Evaluate the Clinical Utility of Specific Autoantibody Testing in Patients With Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600352
• Other study ID #: 2012/245/Cautoantibodies
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: November 6, 2017
• Start date: May 2012
• Est. completion date: April 2017

Study information

• Verified date: November 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Corte TJ, Copley SJ, Desai SR, Zappala CJ, Hansell DM, Nicholson AG, Colby TV, Renzoni E, Maher TM, Wells AU. Significance of connective tissue disease features in idiopathic interstitial pneumonia. Eur Respir J. 2012 Mar;39(3):661-8. doi: 10.1183/09031936.00174910. Epub 2011 Sep 15. — View Citation

de Lauretis A, Veeraraghavan S, Renzoni E. Review series: Aspects of interstitial lung disease: connective tissue disease-associated interstitial lung disease: how does it differ from IPF? How should the clinical approach differ? Chron Respir Dis. 2011;8(1):53-82. doi: 10.1177/1479972310393758. Review. — View Citation

Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194. — View Citation

Friedman AW, Targoff IN, Arnett FC. Interstitial lung disease with autoantibodies against aminoacyl-tRNA synthetases in the absence of clinically apparent myositis. Semin Arthritis Rheum. 1996 Aug;26(1):459-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical utility of specific autoantibody testing	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.	3 months