Status:

RECRUITING

Diagnosis of Graft Pathology by TruGraf

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

Transplant Genomics, Inc.

Conditions:

Acute Graft Rejection

Eligibility:

All Genders

18+ years

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 leverag...

Detailed Description

Given the significant investment of healthcare resources into transplantation, it is critical to identify recipients with graft pathologies such as Acute Cellular Rejection (ACR), NASH, cholestasis, e...

Eligibility Criteria

Inclusion

  • . 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

  • 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.

Key Trial Info

Start Date :

July 20 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 30 2027

Estimated Enrollment :

471 Patients enrolled

Trial Details

Trial ID

NCT06557564

Start Date

July 20 2024

End Date

December 30 2027

Last Update

August 16 2024

Active Locations (1)

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1

Toronto General Hospital -UHN

Toronto, Ontario, Canada, M5G 2N2