Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
Study Type:
Observational
Intervention Category:
Not Applicable
Study Sponsor:
Narkewicz, Michael
Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase:
Other
Recruitment Status:
Recruiting
Study Drug(s):
Not Applicable
Number of Participants Being Recruited:
580
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
CF is characterized by an abnormality in the cystic fibrosis transmembrane conductance regulator (CFTR). In the, liver the role of CFTR is to promote bile flow. The mechanism by which the abnormality in CFTR leads to liver disease in CF is uncertain. The result of liver disease in CF is the development of biliary fibrosis leading to biliary cirrhosis that may progress to multilobular cirrhosis.
There is a need to identify an early marker in patients with CF who are at increased risk for the development of cirrhosis. Timely recognition of these patients would allow for future studies of the pathophysiology of the development of cirrhosis and potentially lead to the development of new treatments. In addition early identification of this subgroup of CF patients allows for close monitoring and prompt assessment of candidates for new treatments if and when they become available.
ELIGIBILITY
Age:
3 Years - 12 Years
FEV1:
Not Applicable
P. aeruginosa status:
Not applicable
B. cepacia status:
Not applicable
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Narkewicz, Michael (720) 777-6669 michael.narkewicz@childrenscolorado.org
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
Emory University (Adult), Atlanta, GA, 30322
Contact Information:
Hunter, Eric Phone: (404) 727-9960 Email: eahunte@emory.edu
IN
Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
Richardson, Stacey Phone: (317) 948-7121 Email: stlyrich@iupui.edu
The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
Contact Information:
Grover, Patricia Phone: (612) 626-7425 Email: Grove026@umn.edu
MO
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
Rodgers, Denise Phone: (314) 286-1176 Email: rodgers@kids.wustl.edu
St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
Contact Information:
Burks, Patricia Phone: (314) 454-5175 Email: Burks_P@kids.wustl.edu
TX
Baylor College of Medicine (Pediatric), Houston, TX, 77030
Contact Information:
Schaap, Nicoline Phone: (832) 822-4252 Email: nxschaap@texaschildrens.org
