NCT01144507|CompletedDMC
Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
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Sponsor study identifier
Secondary identifiers
NIH
observational
774
2 countries
11
Study Start
January 12, 2010
Actual (reported)Primary Completion
February 26, 2021
Actual (reported)Study Completion
June 14, 2023
Actual (reported)The specific aims for this study are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 14, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 12, 2010
Actual (reported)June 14, 2010
Actual (reported)June 15, 2010
Actual (reported)February 26, 2021
Actual (reported)June 14, 2023
Actual (reported)Development of cirrhosis, as defined by imaging criteria
The primary objective of this prospective longitudinal study is to determine the utility of abdominal ultrasound (US) at enrollment to predict the development of cirrhosis in subjects with cystic fibrosis (CF) within a nine year period.
Nine years
Effects on associated pulmonary and nutritional issues
9years
Approximately 60 subjects with a heterogeneous echo pattern of the liver on abdominal ultrasound (HTG US).
Approximately 680 subjects with a normal echo pattern on abdominal ultrasound (NL US). Of these subjects, approximately 110 will be matched 1:1 with Group A participants and followed for the duration of the study. The remaining unmatched subjects will not be followed beyond their initial visit.
An estimated 30 subjects with cirrhosis pattern on abdominal ultrasound. These subjects will be followed in the study.
An estimated 30 subjects with diffusely homogeneous echogenic pattern at screening ultrasound will be followed in the study.
To establish eligibility and/or markers regarding echo pattern types.
The study population will consist of males and females 3 through 12 years of age with Cystic Fibrosis and pancreatic insufficiency who are enrolled in the CFF or Toronto CF registry studies. All racial and ethnic groups will be included.
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
University of Minneapolis Medical Center
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
Siegel MJ, Freeman AJ, Ye W, Palermo JJ, Molleston JP, Paranjape SM, Stoll J, Leung DH, Masand P, Karmazyn B, Harned R, Ling SC, Navarro OM, Karnsakul W, Alazraki A, Schwarzenberg SJ, Seidel FG, Towbin A, Alonso EM, Nicholas JL, Murray KF, Otto RK, Sherker AH, Magee JC, Narkewicz MR; CFLD Network. Heterogeneous Liver on Research Ultrasound Identifies Children with Cystic Fibrosis at High Risk of Advanced Liver Disease: Interim Results of a Prospective Observational Case-Controlled Study. J Pediatr. 2020 Apr;219:62-69.e4. doi: 10.1016/j.jpeds.2019.12.033. Epub 2020 Feb 12.
Siegel MJ, Leung DH, Molleston JP, Ye W, Paranjape SM, Freeman AJ, Palermo JJ, Stoll J, Masand P, Karmazyn B, Harned R, Ling SC, Navarro OM, Karnsakul W, Alazraki A, Schwarzenberg SJ, Towbin AJ, Alonso EM, Nicholas JL, Green N, Otto RK, Magee JC, Narkewicz MR. Heterogeneous liver on research ultrasound identifies children with cystic fibrosis at high risk of advanced liver disease. J Cyst Fibros. 2023 Jul;22(4):745-755. doi: 10.1016/j.jcf.2023.03.019. Epub 2023 Apr 7.
During this study, blood and urine specimens will be obtained, de-identified and shipped to and stored at the NIDDK repositories for use in future CFLD ancillary studies. This "biobanking" is a critical aspect of this longitudinal study to facilitate the creation of a resource of DNA and other specimens from a meaningful number of patients with CFLD. In addition, obtaining and storing DNA or EBV-transformed leukocytes (from which DNA can be extracted) will allow future studies to investigate genetic causes and influences (modifier genes) in CFLD.
Michael Narkewicz, MD
Children's Hospital Colorado
Ed Doo, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Averell Sherker, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
774 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2010
First Posted
June 15, 2010
Study Start
January 12, 2010
Actual (reported)Beta-cell Response to Incretin Hormones in Cystic Fibrosis
Samples of urine, serum, plasma, and blood for DNA from children and blood for DNA from parents will be requested from participating subjects
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
St Louis, Missouri, 63110, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Leung DH, Ye W, Molleston JP, Weymann A, Ling S, Paranjape SM, Romero R, Schwarzenberg SJ, Palermo J, Alonso EM, Murray KF, Marshall BC, Sherker AH, Siegel MJ, Krishnamurthy R, Harned R, Karmazyn B, Magee JC, Narkewicz MR; Cystic Fibrosis Liver Disease Network (CFLD NET). Baseline Ultrasound and Clinical Correlates in Children with Cystic Fibrosis. J Pediatr. 2015 Oct;167(4):862-868.e2. doi: 10.1016/j.jpeds.2015.06.062. Epub 2015 Aug 5.
Primary Completion
February 26, 2021
Actual (reported)Study Completion
June 14, 2023
Actual (reported)Last Updated
April 11, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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