Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias
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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 |
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.
| Estimated Enrollment: | 300 |
| 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 |
|---|
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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).
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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 |
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).
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| Contact: Raven Kidd | 877-587-4411 | raven.kidd@duke.edu |
| Contact: Janet Talbert | 800-423-8891 | talbertj@njhealth.org |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Janet Talbert, MS, CGC 800-423-8891 ext 1022 talbertj@njhealth.org | |
| Principal Investigator: David A Schwartz, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Raven Kidd, BS, CCRC 877-587-4411 raven.kidd@duke.edu | |
| Principal Investigator: Mark P Steele, MD | |
| 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: | November 13, 2012 |
| 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 May 19, 2013