NCT00043225|Completed
The Role of Bacteria and Genetic Variations in Cystic Fibrosis
Clinical Course in Cystic Fibrosis: The Effects of Pseudomonas Aeruginosa and Potential Modifier Genes
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Clinical Course in Cystic Fibrosis: The Effects of Pseudomonas Aeruginosa and Potential Modifier Genes
Sponsor study identifier
Secondary identifiers
observational
76
1 country
4
Study Start
June 20, 2001
Actual (reported)Primary Completion
July 10, 2018
Actual (reported)Study Completion
July 10, 2018
Actual (reported)This study will examine 1) the role of hereditary factors in cystic fibrosis; i.e., 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. ...
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2001
Actual (reported)August 7, 2002
Actual (reported)July 13, 2006
Actual (reported)July 10, 2018
Actual (reported)July 10, 2018
Actual (reported)There is a relationship between the virulence characteristics of P.aeruginosa involved inpersistent infection of the lung and the genetic profile of CF patients.
There is a relationship between the virulence characteristics of P.aeruginosa involved in persistent infection of the lung and the genetic profile of CF patients.
End of study
Antibodies to the components of the type III secretion pathway can be used as an accurate measure of acute infection and colonization of the CF lung by virulent strains of P. aeruginosa. There is a relationship between modifier genotypes and sur...
End of Study
Cystic Fibrosis patients
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.@@@
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066-73. doi: 10.1126/science.2475911.
Rommens JM, Iannuzzi MC, Kerem B, Drumm ML, Melmer G, Dean M, Rozmahel R, Cole JL, Kennedy D, Hidaka N, et al. Identification of the cystic fibrosis gene: chromosome walking and jumping. Science. 1989 Sep 8;245(4922):1059-65. doi: 10.1126/science.2772657.
Joel Moss, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
76 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2006
First Posted
August 7, 2002
Study Start
June 20, 2001
Actual (reported)Primary Completion
Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
Contact the study team to confirm eligibility.
Frizzell RA. Functions of the cystic fibrosis transmembrane conductance regulator protein. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 2):S54-8. doi: 10.1164/ajrccm/151.3_Pt_2.S54.
July 10, 2018
Actual (reported)Study Completion
July 10, 2018
Actual (reported)Last Updated
June 29, 2021
Record last verified: 2021-06
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