Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias

Idiopathic Interstitial Pneumonias Clinical Trial

Official title:

Genetics, Genomics, and Proteomics of Idiopathic Interstitial Pneumonias: Identification of Susceptibility Genes, Biomarkers, and Molecular Phenotyping

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01151527
• Other study ID #: Pro00022485
• Secondary ID: R01HL097163-01RC
• Status: Terminated
• Phase: N/A
• First received: June 25, 2010
• Last updated: September 8, 2015
• Start date: April 2010
• Est. completion date: February 2013

Study information

• Verified date: June 2010
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease.

Description:

The Broad Challenge Area addressed in this proposal is (03) Biomarker Discovery and Validation, and the Specific Challenge Topic is 03-HL-101 (Identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction). Idiopathic interstitial pneumonia (IIP) is a lung disease(s) that primarily affects the elderly, but is present in all age groups. IIP causes respiratory insufficiency and is often fatal. In about half of the patients, the diagnosis requires an invasive lung biopsy which can cause complications, and is not always accurate.

The current diagnostic tools for IIP are inadequate. In addition to inaccurate diagnosis, they are very costly, and often result in delayed diagnosis and treatment. The challenge(s) we intend to address in this proposal is to improve the accurate and early diagnosis of idiopathic interstitial lung pneumonia (IIP), and to improve the ability to differentiate the subtypes of idiopathic interstitial pneumonias (IIPs) by developing peripheral blood biomarkers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 269
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sporadic cases of Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias.

• Family members ( with or without clinical disease) with a family history of pulmonary fibrosis.

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), National Jewish Health, Vanderbilt University

Country where clinical trial is conducted

United States,