Nasal Epithelial Cells/Blood Lymphocyte Markers for CF/CF Pulmonary Exacerbations
Recruitment status was Not yet recruiting
|First Received Date ICMJE||September 27, 2006|
|Last Updated Date||September 27, 2006|
|Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Nasal Epithelial Cells/Blood Lymphocyte Markers for CF/CF Pulmonary Exacerbations|
|Official Title ICMJE||Use of Nasal Epithelial Cells and Blood Lymphocytes to Identify Markers for Cystic Fibrosis and Cystic Fibrosis Pulmonary Exacerbations|
Study Hypothesis: We hypothesize that cellular markers from nasal epithelial cells and blood lymphocytes can serve as potential biomarkers reflect the underlying inflammatory state of the lung and will be helpful in determining the presence of a CF pulmonary exacerbation and its overall severity.
CF is the most common lethal genetic disease in the US afflicting approximately 30,000 people. Chronic disease of the respiratory tract, which is responsible for early death, affects both the upper and lower airways.
We propose to utilize cells (blood lymphocytes and nasal epithelial cells) that are readily accessible and are known to express CFTR and therefore candidates to express markers of the downstream consequences of CFTR deficiency.
A marker that indicates the inflammatory state of the lung would be useful to identify infective/inflammatory exacerbations as opposed to worsening due to pulmonary vascular disease or simply upper airway infection. This marker might help to guide therapy for intensity and duration. Evidence in mice suggest that lymphocytes may be a driving force for inflammation in the CF lung, particularly during exacerbations, and also that human CF lymphocytes have dysfunctional production of cytokines.
To identify markers in nasal epithelial cells or blood lymphocytes that distinguish CF patients from those with functional CFTR (healthy volunteers and patients with asthma). If successful this could become a marker for CFTR correction by drugs or other systemic therapies.
To identify markers in blood lymphocytes that will identify inflammatory status (ie, distinguish an active exacerbation from return to clinical stability) in CF patients. This could become a marker for infectious exacerbations of CF airway disease.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Time Perspective: Longitudinal
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Cystic Fibrosis|
|Intervention ICMJE||Procedure: epithelial cells and blood lymphocyte extraction|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Completion Date||September 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Stable CF Patients:
CF patients with pulmonary exacerbations:
Male of female >= 15 years of age Confirmed diagnosis of CF
Patient meets a modified definition for a pulmonary exacerbation based upon Fuchs criteria which is treated with intravenous antibiotics for any 4 of the following 12 signs or symptoms:
Exclusion criteria for CF patients with pulmonary exacerbation:
Inclusion Criteria - Asthma patients
Exclusion Criteria - Asthma patients
Inclusion Criteria for Healthy Volunteers
Exclusion Criteria for Healthy Volunteers
|Ages||15 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00381628|
|Other Study ID Numbers ICMJE||Protocol 08-06-23|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Hospitals of Cleveland|
|Collaborators ICMJE||Cystic Fibrosis Foundation|
|Information Provided By||University Hospitals of Cleveland|
|Verification Date||September 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP