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临床试验/NCT00228670
NCT00228670已完成不适用

Herpesvirus in Idiopathic Pulmonary Fibrosis

Emory University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Viral load

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Failure of the patient to provide informed consent.

结局指标

主要结局

Viral load

时间窗: 1 year

EBV viral load in induced sputum collected at each clinic visit over a one year period

次要结局

  • Viral load(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arlene Stecenko

Principal Investigator

Emory University

研究点 (1)

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