Specific Autoantibody Testing in Patients With Interstitial Lung Disease
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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 |
Blood
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Patients 21 years old and older
- 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:
- Inability and unwillingness to sign informed consent
- Patients who are pregnant or have underlying malignancy
Contacts and Locations| Contact: Su Ying Low, BMBCh | +65 63214700 | low.su.ying@sgh.com.sg |
| Contact: Andrea Low, MBBS | +65 63214028 | andrea.low.h.l@sgh.com.sg |
| Singapore | |
| Singapore General Hospital | Recruiting |
| Singapore, Singapore, 169608 | |
| Principal Investigator: Su Ying Low, BMBCh | |
| 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 |
| Study First Received: | May 15, 2012 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by Singapore General Hospital:
|
interstitial lung disease idiopathic pulmonary fibrosis |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial Respiratory Tract Diseases |
Autoantibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013