Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015756
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-05-04
Brief Title:
Tissue Collection From People With Cystic Fibrosis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Tissue Collection Protocol for Individuals With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2008-04-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Lungs of individuals with cystic fibrosis CF are frequently colonized with a number of bacterial pathogens One of the most common organisms is Pseudomonas aeruginosa Previous studies have shown the presence of the type III-secretion pathway within P aeruginosa implicating these cytotoxins as virulence factors for this organism To evaluate further the effect of these cytotoxins on lung cells we would like to collect plasma and tissue from individuals with CF Because larger quantities of plasma than can safely be obtained by simple phlebotomy will be required apheresis procedures performed in the Clinical Center Apheresis Unit will be used To obtain lung cells from patients with CF infected with P aeruginosa tissue from explanted lungs will be collected in collaboration with INOVA Fairfax Hospital We intend to look for expression of the type- III proteins of P aeruginosa by measuring the immune response against components of the type- III pathway and their presence in lung cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-H-0163 | None | None | None |