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RecruitingNCT06557564

Diagnosis of Graft Pathology by TruGraf

Development of a Machine Learning Tool for Non-invasive Diagnosis of Liver Graft Pathology Using TruGraf

Sponsor

University Health Network, Toronto

Enrollment

471 participants

Start Date

Jul 20, 2024

Study Type

OBSERVATIONAL

Conditions

Acute Graft Rejection

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria4

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

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Interventions

GENETICTruGraf 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.

Locations(1)

Toronto General Hospital -UHN

Toronto, Ontario, Canada

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NCT06557564