Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228670
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2005-09-27
Brief Title:
Herpesvirus in Idiopathic Pulmonary Fibrosis
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Herpesvirus in Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to 1 to develop a method to quantify Epstein Barr Virus EBV load in lung tissue of humans and to determine whether EBV viral load is significantly higher in lung tissue from patients with idiopathic pulmonary fibrosis IPF than in control lung tissue 2 to determine whether EBV localized to epithelial cells in IPF lungs and to relate epithelial positivity to tissue viral load 3 to measure viral load in induced sputum from IPF subjects over time in order to determine whether periodic active herpes virus replication occurred in the respiratory tract and 4 to compare longitudinal measures of viral load in induced sputum with simultaneously collected saliva in order to assess the clinical utility of the two approaches
Detailed Description:
IPF is a progressive disease where there is no proven treatment other than lung transplant Doctors do not know what causes IPF We think that IPF is caused by a viral infection particularly herpes virus The goal of this experiment is to build the case for a causal link between IPF and herpes virus This information is important to help us develop new therapies to treat patients with IPF
We will collect lung tissue at the time of lung transplant surgery from IPF patients and from organ donors as controls Control lung tissue was collected if it was removed as a part of regular care or would otherwise be discarded No extra tissue was taken solely for this research project
We will also perform a prospective longitudinal study on IPF patients and their household partners IPF subjects are included if they have no other pulmonary disease and the diagnosis of IPF is confirmed by lung biopsy or by clinical and chest CT findings The control group will consist of subjects without respiratory symptoms or pulmonary diseases who are the household partner or spouse of an enrolled IPF subject and who accompanies the IPF patient to outpatient clinic visits If there is no household partner or if the partner is unwilling to participate we will still enroll the IPF subject who qualifies for the study and is willing to participate Saliva induced sputum and venous blood will be collected from IPF and control subjects after informed consent at each clinic visit Visits usually are at approximately 3-4 month intervals over a one year period
We will collect lung tissue at the time of lung transplant surgery from IPF patients and from organ donors as controls Control lung tissue was collected if it was removed as a part of regular care or would otherwise be discarded No extra tissue was taken solely for this research project
We will also perform a prospective longitudinal study on IPF patients and their household partners IPF subjects are included if they have no other pulmonary disease and the diagnosis of IPF is confirmed by lung biopsy or by clinical and chest CT findings The control group will consist of subjects without respiratory symptoms or pulmonary diseases who are the household partner or spouse of an enrolled IPF subject and who accompanies the IPF patient to outpatient clinic visits If there is no household partner or if the partner is unwilling to participate we will still enroll the IPF subject who qualifies for the study and is willing to participate Saliva induced sputum and venous blood will be collected from IPF and control subjects after informed consent at each clinic visit Visits usually are at approximately 3-4 month intervals over a one year period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IPF | OTHER | Other | None |