RECRUITING

Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score \>7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.

Official Title

Exploratory Analysis of Enhanced Liver Function (ELF) Test to Detect Early Fatty Liver in High Risk Population

Quick Facts

Study Start:2023-06-20
Study Completion:2024-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06225193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: ≥ 18 years
  2. * NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
  1. * Patients with incomplete data and those lost to follow up.

Contacts and Locations

Study Contact

Kavya Vinod Mankulangara, PharmD
CONTACT
214-947-4681
MHSIRB@mhd.com
Bethany Brauer, MPH
CONTACT
214-947-4681
mhsirb@mhd.com

Principal Investigator

Parvez Mantry, MD
PRINCIPAL_INVESTIGATOR
Methodist Midlothian Medical Center

Study Locations (Sites)

Methodist Dallas Medical Center
Dallas, Texas, 75203
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Parvez Mantry, MD, PRINCIPAL_INVESTIGATOR, Methodist Midlothian Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2024-06-23

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2024-06-23

Terms related to this study

Additional Relevant MeSH Terms

  • Fatty Liver