Tissue Collection From People With Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT00015756|
Recruitment Status : Completed
First Posted : May 7, 2001
Last Update Posted : July 2, 2017
This study will examine the relationship between bacterial products in lung infections in cystic fibrosis and disease severity. It will examine plasma and lung tissue from cystic fibrosis patients.
Patients with cystic fibrosis and having certain genetic characteristics, who are between 9 and 65 years of age and any cystic fibrosis patient undergoing lung transplantation at INOVA Fairfax Hospital in Fairfax, Virginia, may be eligible for this study.
Patients who cannot undergo apheresis may be asked to provide up to an additional 100 cc (7 tablespoons) of blood for research to look at bacterial products.
Lung specimens of participating transplant patients will be collected at INOVA Fairfax Hospital. Patients who participate in the apheresis portion of the study will be admitted to the NIH Clinical Center for 2 to 3 days. Apheresis is a procedure for collecting large quantities of specific blood components. For this study, plasma-the liquid part of the blood-will be collected. For the procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated into its components by centrifugation (spinning), the plasma and white cells are extracted and collected in a bag, and the red cells are returned to the body, either through the same needle or through another needle in the other arm.
During the hospital stay, patients may also be asked to participate in other cystic fibrosis studies involving blood tests, an echocardiogram (ultrasound test of the heart), urine pregnancy test, and pulmonary function (breathing) tests.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Tissue Collection Protocol for Individuals With Cystic Fibrosis|
|Study Start Date :||May 2, 2001|
|Estimated Study Completion Date :||April 21, 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015756
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Wisconsin|
|Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226|
|Milwaukee, Wisconsin, United States, 53226|