Status:
COMPLETED
Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Pancreatic Insufficiency
Eligibility:
All Genders
3-12 years
Brief Summary
The specific aims for this study are: 1. To determine if sonographic findings predict the risk of progression of liver disease to cirrhosis by comparing cystic fibrosis subjects with heterogeneous ec...
Detailed Description
For subjects in longitudinal follow up, this study will: 1. Collect detailed clinical and demographic information about each subject at enrollment and during follow up, 2. Obtain and store imaging da...
Eligibility Criteria
Inclusion
- Children aged 3 through 12 years of age at time of enrollment diagnosed with Cystic Fibrosis and pancreatic insufficiency
- Enrolled in the CFF registry study or Toronto CF Registry
- CF defined as sweat chloride of \>60 mEq/L on one occasion (using the value in the CF registry) or two disease-causing mutations of CFTR with evidence of end organ involvement.
- Pancreatic insufficient defined as one of the following:
- CFTR Mutation associated with pancreatic insufficiency
- Fecal elastase \<100 mcg/gm (at any time)
- 72 hour fecal fat with coefficient of fat absorption \<85% (at any time)
Exclusion
- Known cirrhosis
- Presence of Burkholderia cepacia
- Short bowel syndrome defined as not on full enteral feeds by 3 months of age
- Presence of other serious disease precluding participation in this study (This would include patients with known other causes of chronic liver disease)
- If in the opinion of the Investigator the study is not in the best interest of the patient
- Inability to comply with the longitudinal follow-up described below
- Failure of a family to sign the informed consent document or the HIPAA medical record release form
Key Trial Info
Start Date :
January 12 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
774 Patients enrolled
Trial Details
Trial ID
NCT01144507
Start Date
January 12 2010
End Date
June 14 2023
Last Update
April 11 2025
Active Locations (11)
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1
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
Ann & Robert H. Lurie Children's Hospital of
Chicago, Illinois, United States, 60611
4
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202