Liver Disease Scarring: The FORCE Study

FibroScan® in Pediatric Cholestatic Liver Disease Study

Protocol Description

The purpose of this multi-center observational investigation is to test the utility of a type of painless ultrasound technology, called the FibroScan® device, for measuring progression of liver scar tissue growth (liver fibrosis) in children and young adults with liver disease. Noninvasive monitoring of liver fibrosis is an unmet and critical need within the clinical management of children with chronic liver disease. Through the study, researchers will measure liver stiffness, an indication of scarring, using a noninvasive assessment technology called transient elastrography.

Eligibility Criteria

Patients up to age 21 who are being treated for liver disease and who are already enrolled in one of the studies being conducted as part of the Childhood Liver Disease Research Network (ChiLDReN) are being invited to participate in this study. The other ChiLDReN studies include BASIC, LOGIC, and PROBE.
Males and Females: Up to age 21

Requirements

With permission, participants’ medical records will be accessed for past laboratory values and other relevant information. Blood samples will be taken, and researchers will provide a physical examination of participants, followed by examination using the FibroScan transient elastrography device, a type of ultrasound. The tests will be repeated twice annually.
Visits: 3, which may be done as part of regular clinical care
Duration: 2 years

Status: Enrolling by Invitation

Source(s) of Support

National Institute of Diabetes and Digestive and Kidney Diseases
Arbor Research Collaborative for Health

Primary Investigator

Robert H. Squires, MD

Contact Information

For more information about the study or enrollment, please contact:
Kathy Bukauskas, RN, CCRC
412-692-7703