Identifying liver transplant issues using a blood test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify various causes of liver diseases in liver transplant patients by developing a machine learning algorithm that utilizes gene expression and clinical information. Participants will provide blood samples, which will be analyzed using the TruGraf test, a non-invasive method that measures gene expression to assess liver health. The results from the TruGraf test will be compared with liver biopsy outcomes to improve the accuracy of diagnosing graft pathologies such as Acute Cellular Rejection. The goal is to enable earlier and safer interventions for patients experiencing graft issues.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. . Single-organ Liver transplant recipients
2. Male or female, age \> 18 years at the time of signing informed consent.
3. Willing and able to provide informed consent.
4. Patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent.

Exclusion Criteria:

1. Repeat transplant
2. Recipient of multi organ transplantation
3. Any treatment for graft rejection such as IV steroids has been given before biopsy.
4. Targeted biopsies for diagnosis of malignancy.

Where it's running

• Toronto General Hospital -UHN
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mamatha Bhat, MD — Uhn
• Study coordinator: Sameera Rizvi
• Email: sameera.rizvi@uhn.ca
• Phone: 4163404800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.