Viewing Study NCT00043225



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00043225
Status: COMPLETED
Last Update Posted: 2021-06-29
First Post: 2006-07-13

Brief Title: The Role of Bacteria and Genetic Variations in Cystic Fibrosis
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Clinical Course in Cystic Fibrosis The Effects of Pseudomonas Aeruginosa and Potential Modifier Genes
Status: COMPLETED
Status Verified Date: 2021-06
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 1 the role of hereditary factors in cystic fibrosis ie the relationship of the disease to specific gene variations and 2 the role of bacterial products involved in lung infections substances produced by bacteria may worsen the disease

Patients with cystic fibrosis who are being followed by the Medical College of Wisconsin or the University of Wisconsin-Madison are eligible for this study Participants will have blood tests pulmonary function tests a sputum culture and buccal swabbing cotton swabbing of the inside of the cheek to collect cells for DNA study In addition their medical records will be reviewed for a history of lung infections and the results of various tests including pulmonary function studies chest X-rays and bacterial cultures Blood samples collected previously at the Medical College of Wisconsin or the University of Wisconsin-Madison will also be analyzed for antibodies to bacteria

Although this is a one-time study participants may be asked to return for repeated tests

Detailed Description: Individuals with cystic fibrosis CF are susceptible to chronic bacterial colonization by Pseudomonas aeruginosa which results in deterioration of lung function and eventually death In this study we hope to improve our understanding of the innate immune response to infection by strains of P aeruginosa that express type III cytotoxins and to delineate better the role of modifier genes in disease progression

We will examine relationships between the patients clinical course the presence of antibodies to P aeruginosa and single nucleotide polymorphisms in suspected CF modifier genes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
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-0198 None None None