Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias

This study has been terminated.
Sponsor:
Collaborators:
National Jewish Health
Vanderbilt University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01151527
First received: June 25, 2010
Last updated: May 20, 2013
Last verified: June 2010
  Purpose

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
Idiopathic Interstitial Pneumonias

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

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.


Enrollment: 28
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Jewish Health
Vanderbilt University
Investigators
Principal Investigator: Mark P Steele, MD Duke University
Principal Investigator: David A Schwartz, MD National Jewish Health
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01151527     History of Changes
Other Study ID Numbers: 3524 (RC1 -HL099571), R01HL097163-01
Study First Received: June 25, 2010
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014