RECRUITING

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

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

Nonalcoholic Steatohepatitis (NASH) is a condition with increased amount of fat, inflammation and scarring in the liver. In compensated cirrhosis, the liver is coping with this damage and maintaining its important functions. Decompensation occurs when the liver becomes unable to perform all of its functions adequately. Variceal hemorrhage (bleeding from abnormal vessels in the liver called varices), Ascites (abnormal build-up of fluid in the abdomen), and Encephalopathy (brain confusion as a result of the liver not being able to get rid of toxic substances) are three symptoms of liver decompensation. The purpose of this research study is to investigate better ways to routinely monitor the condition of patients with NASH with compensated cirrhosis and to better pinpoint the development of decompensation in the livers of these patients.

Official Title

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Quick Facts

Study Start:2023-04-19
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05720663

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. * Cirrhosis: biopsy confirmed or Agile F (F4) score \> 0.45
  2. * NAFLD as an etiology of liver disease will be determined based on presence of any of the following:
  3. * Biopsy showing \>5% steatosis or
  4. * CAP \> 280 dB/m or MR-PDFF\>5%
  5. * If CAP \< 280 dB/m or MR-PDFF \<5%, then must have type 2 diabetes and or 2 or more features of metabolic syndrome for 5 years (cryptogenic cirrhosis)
  1. * Refusal to consent
  2. * Alcohol use \> 14/21 gm/week cutoff
  3. * Other causes of chronic liver disease
  4. * MELD \> 12
  5. * Hepatic and extrahepatic cancers expected to limit life expectancy \< 2 yrs
  6. * prior hepatic resections, TIPS, splenic embolization
  7. * prior decompensation events
  8. * inability to fit into MRI (failed hula-hoop test)
  9. * general contraindication for MRI contrast (GFR \< 30 ml/min)
  10. * contraindications for MRI
  11. * pregnancy
  12. * acute kidney injury
  13. * reduced kidney function (GFR \<30ml/min)

Contacts and Locations

Study Contact

Mohammad S Siddiqui, MD
CONTACT
804-828-4060
mohammad.siddiqui@vcuhealth.org

Principal Investigator

Mohammad S Siddiqui, MD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Mohammad S Siddiqui, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

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 Date2023-04-19
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-04-19
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Nonalcoholic Steatohepatitis