A 5-Year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver or Nonalcoholic Steatohepitiis

Niharika Samala, MD

Primary Investigator

Enrolling By Invitation
2 years - 100 years
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to create a research registry of patients with NAFL (non alcoholic fatty liver) or NASH (non alcoholic steatohepatitis)in order to assess the safety and effectiveness of current and future therapies. The goal is to identify the factors associated with favorable versus suboptimal clinical response to improve health and reduce the development of liver cancer in this patient population.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

Patients enrolled in TARGET-NASH will be invited to participate in the Biorepository Specimen Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the patient's unique study ID number and the date that the sample was obtained. This link between the patient's study ID number and their name will be available only at the site where the samples were obtained.
 
Subjects will return for an annual visit for an indefinite duration. At each visit, information about their health will be collected. Subjects will complete several quality of life surveys either in person or electronically and may participate in an optional blood draw. Health information will be collected approximately every six months via health records of the participants. Participants are being given the option to allow for their records and blood samples to be linked.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nonalcoholic Fatty Liver, Nonalcoholic Steatohepitiis, NASH, NAFLD
  • Age: 2 years - 100 years
  • Gender: All

Inclusion Criteria:

1. Adults and children (age 2 or older) being managed or treated for nonalcoholic fatty liver disease. Diagnosis is based on the clinical judgement of the care provider.

Exclusion Criteria:

1. Inability to provide informed assent/consent.

Study Population
Adults and children with NAFL or NASH who are being seen specifically to address this disease process

Updated on 16 Dec 2025. Study ID: GI-TARGET-SAMALA-NASH, 1705324897
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only