Herpesvirus in Idiopathic Pulmonary Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/12/2017 |
| Start Date: | July 2005 |
| End Date: | August 2012 |
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.
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.
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.
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.
For the study on lung tissue, eligible subjects were IPF patients undergoing lung
transplant surgery and from organ donors who died from non-pulmonary causes. For the study
in clinic, subjects were IPF patients who had no other pulmonary disease other than IPF
and the diagnosis of IPF was confirmed by lung biopsy or by clinical and chest CT
findings. The control group consisted of subjects without respiratory symptoms or
pulmonary diseases who were the household partner or spouse of an enrolled IPF subject and
accompanied the IPF patient to outpatient clinic visits.
Exclusion Criteria:
- Failure of the patient to provide informed consent.
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