Herpesvirus in Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arlene Stecenko, Emory University
ClinicalTrials.gov Identifier:
NCT00228670
First received: September 27, 2005
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition
Lung Diseases
Herpesvirus Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Herpesvirus in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Viral load [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    EBV viral load in induced sputum collected at each clinic visit over a one year period


Secondary Outcome Measures:
  • Viral load [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    EBV viral load in saliva collected every clinic visit over a one year period


Other Outcome Measures:
  • Viral load [ Time Frame: one time point ] [ Designated as safety issue: No ]
    EBV viral load in lung tissue collected at the tim e of lung transplantation


Biospecimen Retention:   Samples Without DNA

Lung tissue at the time of lung transplantation. Saliva, induced sputum, and blood at clinic visitis


Enrollment: 41
Study Start Date: July 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
IPF-Clinic
Adult patients with idiopathic pulmonary fibrosis being followed in pulmonary clinic
Controls - Clinic
Adult subjects with no underlying pulmonary disease who are the household partner of an IPF patient being followed in pulmonary clinic
IPF-Transplant
IPF patient undergoing lung transplant
Controls-Transplant
Lung tissue from organ donor

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with idiopathic pulmonary fibrosis (IPF) or controls with no underlying pulmonary disease

Criteria

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.
  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: NCT00228670

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Arlene Stecenko, MD Emory University
  More Information

No publications provided

Responsible Party: Arlene Stecenko, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00228670     History of Changes
Other Study ID Numbers: IRB00041094, IPF
Study First Received: September 27, 2005
Last Updated: December 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Idiopathic Pulmonary Fibrosis
herpesvirus
lung biopsy
Having diagnosed lung disease
Scheduled to have a lung biopsy as part of the evaluation for your lung disease

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Herpesviridae Infections
Pathologic Processes
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014