Lung DiseasesNCT00228670
Herpesvirus in Idiopathic Pulmonary Fibrosis
An observational study of Lung Diseases and Herpesvirus Infections, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Herpesvirus Infections
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with idiopathic pulmonary fibrosis (IPF) or controls with no underlying pulmonary disease
Who may be able to join
None listed.
Who cannot join
- Failure of the patient to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Diseases, Herpesvirus Infections
- Keywords
- 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
- Medical subject headings
- Lung Diseases, Herpesviridae Infections, Idiopathic Pulmonary Fibrosis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
EBV viral load in induced sputum collected at each clinic visit over a one year period
Measured: 1 year
Secondary outcomes (1)
Viral load
EBV viral load in saliva collected every clinic visit over a one year period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlene Stecenko, Emory University
- Investigators
- Arlene Stecenko, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228670
- Sponsor's protocol ID
- IRB00041094
- Other IDs
- IPF
- Status last verified
- May 2017
- First submitted
- 27 Sep 2005
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herpesvirus in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00228670
- Acronym / sponsor ID
- IRB00041094
- Conditions
- Lung Diseases, Herpesvirus Infections
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with idiopathic pulmonary fibrosis (IPF) or controls with no underlying pulmonary disease
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Failure of the patient to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral load
Time frame: 1 year
EBV viral load in induced sputum collected at each clinic visit over a one year period
1 secondary outcome
Viral load
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Stecenko, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Herpesvirus Infections, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.