By InvitationNot Applicable

North Jersey Community Research Initiative (NJCRI) Study on Transgender Liver Health

United States60 participantsStarted 2025-03-15

Plain-language summary

Primary Objective: Assess disparities in liver health outcomes among transgender individuals on GAHT by evaluating liver function markers (transaminases, bilirubin levels, etc), as well as liver elasticity and presence of liver steatosis or Nonalcoholic Fatty Liver Disease (NAFLD) through FibroScan. A total of 60 participants will be recruited throughout the study, with a ratio of 1:1 between transgender participants who have been on GAHT more than 6 months ( = or \> 182 days), and transgender participants who have been on GAHT for less than 6 months ( \< 181 days) at the start of the study. Secondary Objectives: Assess liver health-related risk factors (e.g. obesity, alcohol consumption) in transgender population. Investigate the association between specific hormone regimens and liver function in transgender individuals. Explore potential modifiers of liver health outcomes, such as age, social barriers determinants of health, duration of hormone therapy and adherence to medical guidelines. Change in Quality of Life from baseline to last study visit.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Transgender individuals (18 years or older). Individuals who are able to write and/or read in English. - Exclusion Criteria: * Inability to provide informed consent Individuals with known decompensated liver cirrhosis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess disparities in liver health outcomes among transgender individuals

Timeframe: Baseline through December 2027

Assess Elasticity of liver

Timeframe: Baseline through December 2027

Trial details

NCT IDNCT07746999

SponsorCorey DeStefano

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-15

View on ClinicalTrials.gov More HEPATITIS C (HCV) trials