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Diagnosis of Graft Pathology by TruGraf

NCT06557564 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 471

Last updated 2024-08-16

No results posted yet for this study

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.

Conditions

  • Acute Graft Rejection

Interventions

GENETIC

TruGraf liver gene expression

Blood from the patients undergoing graft liver biopsy will be collected on the day of the liver biopsy, preferable prior to tissue collection or within 48 hours following the biopsy. Two specialized PaxGene tubes containing 2.5mL of blood each will be filled and will be sent to TGI laboratory in USA for processing, storage, and analysis using TGI's proprietary bioinformatics TruGraf will provide UHN with a Liver binary result: ACR or non-ACR. The results data will be batched and sent to UHN at agreed upon timepoints.

Sponsors & Collaborators

  • Transplant Genomics, Inc.

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Mamatha Bhat, MD · UHN

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2027-07-20
Completion
2027-12-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557564 on ClinicalTrials.gov