Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias

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

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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Interstitial Pneumonias

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 269

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We are recruiting patients with Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias that occur sporadically or familial (2 or more affected individuals in a family).

Description

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:

• None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Sporadic (idiopathic) or familial interstitial pneumonia; We are recruiting patients with Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias that occur sporadically or familial (2 or more affected individuals in a family). Participation can be done by mail or visiting Duke University Medical Center (Durham, NC)or National Jewish Health (Denver, CO).

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Vanderbilt University; National Jewish Health
• Investigators: Principal Investigator: Mark P Steele, MD, Duke University; Principal Investigator: David A Schwartz, MD, National Jewish Health

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 25, 2010
• First Posted (Estimate): June 28, 2010

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Idiopathic Pulmonary Fibrosis; Pneumonia; Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias; Hamman-Rich Syndrome
• Other Study ID Numbers: Pro00022485; R01HL097163-01 (U.S. NIH Grant/Contract); RC1HL099571 (U.S. NIH Grant/Contract)