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Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias

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ClinicalTrials.gov Identifier: NCT01151527
Recruitment Status : Terminated
First Posted : June 28, 2010
Last Update Posted : September 9, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
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 Design

Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Genetics, Genomics, and Proteomics of Idiopathic Interstitial Pneumonias: Identification of Susceptibility Genes, Biomarkers, and Molecular Phenotyping
Study Start Date : April 2010
Primary Completion Date : February 2013
Study Completion Date : February 2013


Groups and Cohorts

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).


Outcome Measures

Biospecimen Retention:   Samples With DNA

Tubes of blood will be drawn from the subject to extract RNA and DNA for laboratory purposes.

Lung biopsy tissue (pathology slides) may be requested for specimen processing.

Also Bronchoscopy fluid may be requested.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151527


Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
National Jewish Health
Vanderbilt University
Investigators
Principal Investigator: Mark P Steele, MD Duke University
Principal Investigator: David A Schwartz, MD National Jewish Health
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01151527     History of Changes
Other Study ID Numbers: Pro00022485
R01HL097163-01 ( U.S. NIH Grant/Contract )
RC1HL099571 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: June 2010

Additional relevant MeSH terms:
Pneumonia
Lung Diseases, Interstitial
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections