NCT02348814

Brief Summary

The overall aim of this study is to validate a quantitative digital tool for staging liver fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3.7 years

First QC Date

January 14, 2015

Last Update Submit

April 15, 2019

Conditions

Liver Fibrosis

Keywords

NAFLD, NASH

Outcome Measures

Primary Outcomes (1)

  • Composite of Clinical Outcomes-change over time

    Date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer (liver-related or otherwise), and death

    Participants will be followed up to 24 months; measured outcomes at 8 timepoints

Secondary Outcomes (1)

  • Composite of Morphometric Outcomes-change over time

    Participants will be followed up to 24 months; measured outcomes at 8 timepoints

Other Outcomes (1)

  • Composite of Biochemical Outcomes-change over time

    Participants will be followed up to 24 months; measured outcomes at 8 timepoints

Study Arms (8)

normal weight

BMI 20-25

overweight

BMI 25-30

obese

BMI 30-35

morbidly obese

BMI \> 35

non-diabetic

HgbA1c (\<5.7%) and blood glucose (65-99 mg/dL) within normal range as defined at UCLA Clinical Lab

diabetic

HgbA1c (\>6.5%) and blood glucose (\>100 mg/dL) as defined at UCLA Clinical Lab

non-cirrhotic

Normal liver function tests (AST/SGOT, ALT, SGPT, alkaline phosphatase, bilirubin) as defined at UCLA Clinical Lab

dyslipidemic

Abnormal lipid profile (Total cholesterol \>170 mg/dL, LDL \>100 mg/dL, HDL \>130 mg/dL, triglycerides \>150 mg/dL) as defined at UCLA Clinical Lab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects 18 years and older with at least one liver function test abnormality and body mass index \> 20.

You may qualify if:

  • Age \>/= 18 years
  • At least one liver function test abnormality (AST/SGOT, ALT/SOT, alkaline phosphatase, or bilirubin) defined as a value outside of the normal range at UCLA clinical labs. This must be present on at least two occasions within a 24 month consecutive period
  • Any body mass index \> 20
  • One of the following:
  • Clinical indication, according to standard of care assessment, for undergoing image-guided percutaneous (or transjugular) liver biopsy
  • Eligible for weight loss (bariatric) surgery with fatty liver disease
  • NAFLD/NASH patient who meets the above criteria and has already undergone a liver biopsy for diagnosis and disease staging
  • NAFLD/NASH patient who meets above criteria but chooses not to participate in the liver biopsy, extra blood draws or the dietary assessment for the study.

You may not qualify if:

  • Age \< 18 years
  • Current pregnancy
  • Significant clinical co-morbidities that would preclude getting either a percutaneous or transjugular liver biopsy (i.e. platelets \< 50, 000 or International Normalized Ratio (INR) \> 1.5 or Hemoglobin \< 8)
  • Unwilling or unable to participate or consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Clinical and Translational Research Center (CTRC)

Los Angeles, California, 90095, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimens include inflammatory markers (cytokines) and markers of metabolic dysfunction (adipokines): leptin, adiponectin, TNF-alpha, PAI-1, IL-6, MCP-1, and retinoids

MeSH Terms

Conditions

Liver CirrhosisNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsFatty Liver

Study Officials

  • Simon Beaven, MD/PhD

    UCLA Dept of Medicine, Division of Digestive Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 28, 2015

Study Start

May 1, 2015

Primary Completion

January 26, 2019

Study Completion

February 26, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)