Study Results
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Basic Information
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COMPLETED
1248 participants
OBSERVATIONAL
2004-10-31
2018-12-31
Brief Summary
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Detailed Description
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The EPIC Observational Study will serve as a freestanding epidemiologic study of the risk factors for and clinical impact of initial Pa acquisition and anti-pseudomonal therapy. Defining the risk factors for Pa acquisition can potentially allow for preventive measures and identification of high-risk populations requiring closer monitoring. Despite rigorous data collection, previous studies have been limited by small sample sizes and by conduct at one or two centers. This study will include a much larger sample size from many more centers than previous studies. It will thus provide for more generalizable results and more precise risk estimates for previously identified risk factors for Pa acquisition, and it will allow for exploration of novel risk factors not included in earlier studies. Better understanding of the clinical outcomes associated with Pa acquisition and the outcomes associated with different types of anti-pseudomonal therapies will inform the development of rational early intervention treatment regimens. Better knowledge about temporal relationships between respiratory signs and symptoms, Pa serology, and CF airway microbiology may lead to improved strategies for early detection of Pa and could have important implications for the timing of interventions aimed at preventing or treating early Pa acquisition. Finally, this study will serve as an important source of Pa and S. aureus isolates, serum samples, and DNA samples that will be used and banked for studies designed to enhance the understanding of the pathogenesis of CF, e.g., microarray investigations of early Pa isolates, investigations to identify proteomic biomarkers of airway inflammation, and investigations to identify genetic factors related to CF disease progression, including early lung disease, and clinical outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Pa negative or concurrently enrolled in the EPIC Clinical Trial
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CF based upon the criteria established by the 1997 CF Consensus Conference: (i) sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis; or (ii) genotype with two identifiable mutations consistent with CF; or (iii) an abnormal nasal transepithelial potential difference, and (iv) one or more clinical features consistent with CF.
* No prior isolation of Pa from respiratory cultures (1 or more cultures in 24 months prior to enrollment), or, if prior isolation of Pa from respiratory cultures, at least a two-year history of Pa negative cultures (1 or more cultures/year), or concurrently enrolled in the EPIC Clinical Trial.
* Signed informed consent to participate in data submission to the CFF National Patient Registry.
* Signed informed consent by parent or legal guardian.
12 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
CF Therapeutics Development Network Coordinating Center
NETWORK
Responsible Party
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Principal Investigators
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Margaret Rosenfeld, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Ronald L. Gibson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Wayne J. Morgan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona Health Sciences Center
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hospital of Los Angeles / USC Medical School
Los Angeles, California, United States
Kaiser Permanente Medical Center
Oakland, California, United States
Packard Children's Hosp., Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's Hospital Denver
Denver, Colorado, United States
duPont Hospital for Children
Wilmington, Delaware, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
All Children's Hospital CF Center
St. Petersburg, Florida, United States
Emory University, Cystic Fibrosis Center
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Riley Hospital, Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Children's Hospital, Boston
Boston, Massachusetts, United States
University of Mass Memorial Health Care
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Spectrum Health Hospitals - DeVos Children's Hospital
Grand Rapids, Michigan, United States
Children's Hospitals & Clinics
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital - St. Louis University
St Louis, Missouri, United States
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Albany Medical College
Albany, New York, United States
Women & Children's Hospital of Buffalo
Buffalo, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
New York Medical College/Westchester Medical Center
Valhalla, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Rainbow Babies & Childrens Hospital
Cleveland, Ohio, United States
Children's Hospital
Columbus, Ohio, United States
Children's Medical Center
Dayton, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
LeBonheur Children's Medical Center
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Vermont Children's Hospital at Fletcher Allen Health Care
Burlington, Vermont, United States
Children's Hospital & Regional Medical Center
Seattle, Washington, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Rosenfeld M, Emerson J, McNamara S, Thompson V, Ramsey BW, Morgan W, Gibson RL; EPIC Study Group. Risk factors for age at initial Pseudomonas acquisition in the cystic fibrosis epic observational cohort. J Cyst Fibros. 2012 Sep;11(5):446-53. doi: 10.1016/j.jcf.2012.04.003. Epub 2012 May 1.
Rosenfeld M, Emerson J, McNamara S, Joubran K, Retsch-Bogart G, Graff GR, Gutierrez HH, Kanga JF, Lahiri T, Noyes B, Ramsey B, Ren CL, Schechter M, Morgan W, Gibson RL; EPIC Study Group Participating Clinical Sites. Baseline characteristics and factors associated with nutritional and pulmonary status at enrollment in the cystic fibrosis EPIC observational cohort. Pediatr Pulmonol. 2010 Sep;45(9):934-44. doi: 10.1002/ppul.21279.
Treggiari MM, Rosenfeld M, Mayer-Hamblett N, Retsch-Bogart G, Gibson RL, Williams J, Emerson J, Kronmal RA, Ramsey BW; EPIC Study Group. Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'. Contemp Clin Trials. 2009 May;30(3):256-68. doi: 10.1016/j.cct.2009.01.003. Epub 2009 Jan 15.
Other Identifiers
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EPIC002
Identifier Type: -
Identifier Source: org_study_id
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