Identifying liver transplant issues using a blood test
Development of a Machine Learning Tool for Non-invasive Diagnosis of Liver Graft Pathology Using TruGraf
University Health Network, Toronto · NCT06557564
This study is testing a blood test that looks at gene information to see if it can help doctors find liver problems earlier in patients who have had a liver transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 471 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06557564 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are single-organ liver transplant recipients aged over 18 who are undergoing or have recently had a liver biopsy.
Not a fit: Patients who have undergone repeat transplants or multi-organ transplants, or those receiving treatment for graft rejection prior to biopsy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early diagnosis of liver transplant complications, potentially improving patient outcomes.
How similar studies have performed: Other studies utilizing gene expression profiling for diagnosing transplant-related issues have shown promise, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Graft Rejection, Liver transplant patients