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Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis

NCT01144507 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 774

Last updated 2025-04-11

No results posted yet for this study

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 echogenicity pattern on ultrasound to those with normal echogenicity pattern on ultrasound
2. To develop a database and biorepository of serum, plasma, urine and DNA to aid the investigations in ascertaining the mechanisms, consequences, genetic risk factors and biomarkers for the development of cirrhosis
3. To determine if there are differences in health related quality of life, pulmonary or nutritional status in children with cystic fibrosis who have a heterogeneous echo pattern on ultrasound compared to those who have a normal echo pattern on ultrasound
4. To determine if Doppler velocity measurements of hepatic and splenic vessels predict an increased risk for the development of cirrhosis.
5. To determine if cirrhosis on ultrasound progresses to portal hypertension during the study period
6. To determine if homogeneous liver progresses to either cirrhosis or heterogeneous liver.
7. To determine the frequency of complications of portal hypertension during follow up in those identified with cirrhosis by year 6 of the study

Conditions

Interventions

PROCEDURE

Abdominal Ultrasound

To establish eligibility and/or markers regarding echo pattern types.

OTHER

Sample collection procedures

Samples of urine, serum, plasma, and blood for DNA from children and blood for DNA from parents will be requested from participating subjects

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • 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)

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-12
Primary Completion
2021-02-26
Completion
2023-06-14

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144507 on ClinicalTrials.gov