Clinical trial NCT00258544: Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)
Official title: Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Fibrosis
Keywords: Lung
Fibrosis
Idiopathic
Microarray
Tissue
Biopsy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-11-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population includes any patients seen at the Simmons Center for Interstitial Lung Disease with the possibility of having the diagnosis of Idiopathic Pulmonary Fibrosis who's physician has ordered an open Lung Biopsy. To check for the disease also known as IPF.

Brief summary: This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. The identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

Detailed description: Subjects are being asked to participate in a research study that is investigating the way the lung is damaged in a condition called pulmonary fibrosis. These research studies are conducted in the laboratory on a portion of the tissue from the subject's lung biopsy that was performed by a surgeon. The lung biopsy is to be performed for clinical purposes to diagnose the cause of the subject's lung disease. The tissue used for the research study will in no way interfere with the ability of the pathologist to establish a diagnosis. In addition, the results of your breathing tests, chest X-rays and CT scans, and diagnosis made from the lung biopsy (and slides) will be collected. The goal of the study is to gain an understanding of the causes of pulmonary fibrosis and why it gets worse, which may ultimately lead to new therapies for this disease. Once the lung biopsies are obtained, the pathologist will examine the tissue and determine if there is a sufficient amount available to use in the study without compromising their ability to make a diagnosis. If so, the lung biopsy will be divided. One portion will be submitted to the research study and the other processed by the pathologist in the usual manner to make a diagnosis. The decision to use tissue for the research study will be at the complete discretion of the pathologists. The tissue used in the study will be further processed in the laboratory in order to analyze for the presence of genetic markers in the scarred tissue that are not present in normal. The identification of these unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

Eligibility criteria: Inclusion Criteria:

* 18 years or age or older
* Diagnosis of pulmonary fibrosis
* Undergoing open lung biopsy

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
name: Kevin F Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pandit KV, Corcoran D, Yousef H, Yarlagadda M, Tzouvelekis A, Gibson KF, Konishi K, Yousem SA, Singh M, Handley D, Richards T, Selman M, Watkins SC, Pardo A, Ben-Yehudah A, Bouros D, Eickelberg O, Ray P, Benos PV, Kaminski N. Inhibition and role of let-7d in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2010 Jul 15;182(2):220-9. doi: 10.1164/rccm.200911-1698OC. Epub 2010 Apr 15.