Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 23
Healthy Volunteers: f
View:

• Age 6-23 years old.

• Established clinical diagnosis of AIH or PSC.

Locations
United States
Ohio
Cincinnati Children's Hospital and Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Alexander Miethke, MD
alexander.miethke@cchmc.org
513-636-8948
Backup
Cyd Castro Rojas, PhD
cyd.castrorojas@cchmc.org
513-517-0580
Time Frame
Start Date: 2017-02-20
Estimated Completion Date: 2031-02
Participants
Target number of participants: 150
Treatments
Patients with autoimmune liver disease
Patients with autoimmune liver disease~Patients (6-23 y.o.) with established clinical diagnosis of AIH or suspected diagnosis of AIH based on elevated serum AST or ALT, elevated IgG level \>1.1 ULN, elevated titer of autoantibodies, including ANA, SMA, LKM, LC-1 or SLA, which is consistent with the simplified criteria for the diagnosis of AIH in children will be enrolled.~Patients (6-23 y.o.) with established clinical diagnosis of PSC or Suspected diagnosis of PSC supported by abnormal cholangiogram (ERCP or MRCP) or elevated GGT\>1.5 ULN and dilated bile ducts by liver ultrasound will be enrolled.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov