Trial record 5 of 149 for:    Open Studies | "Lung Diseases, Interstitial"

Specific Autoantibody Testing in Patients With Interstitial Lung Disease

This study is currently recruiting participants.
Verified May 2012 by Singapore General Hospital
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01600352
First received: May 15, 2012
Last updated: May 16, 2012
Last verified: May 2012
  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:

Biospecimen Retention:   Samples Without DNA

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)
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

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600352

Contacts
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

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Principal Investigator: Su Ying Low, BMBCh         
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
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
Lung Diseases, Interstitial
Respiratory Tract Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014