NCT06557564 Diagnosis of Graft Pathology by TruGraf
| NCT ID | NCT06557564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Acute Graft Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 471 participants |
| Start Date | 2024-07-20 |
| Primary Completion | 2027-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 471 participants in total. It began in 2024-07-20 with a primary completion date of 2027-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to to identify different causes of liver diseases or damage in liver transplant patients and develop a machine learning algorithm as a non-invasive tool leveraging gene expression and patient clinical information to classify transplant liver diseases We will collect blood samples of the participants who had undergone or will undergo the liver biopsy as part of standard of care, and use this blood in TruGarf. TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to rule out liver damage. Researcher will collect the biopsy result from the medical record and this will be compared with the TruGarf results.
Eligibility 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.
Contact & Investigator
Mamatha Bhat, MD
PRINCIPAL INVESTIGATOR
UHN
Frequently Asked Questions
Who can join the NCT06557564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Graft Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557564 currently recruiting?
Yes, NCT06557564 is actively recruiting participants. Contact the research team at sameera.rizvi@uhn.ca for enrollment information.
Where is the NCT06557564 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06557564 clinical trial?
NCT06557564 is sponsored by University Health Network, Toronto. The principal investigator is Mamatha Bhat, MD at UHN. The trial plans to enroll 471 participants.