Diagnosis of Graft Pathology by TruGraf

NCT ID: NCT06557564

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 471 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2027-12-30

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.

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, etc. at an earlier stage to implement the appropriate intervention, rather than initiating empiric treatment that could be unsafe. This project will develop a practical Machine learning-based tool based on the results of the TruGraf assay alongside clinical and laboratory data for non-invasive diagnosis of graft pathology. TruGraf is a non-invasive test that measures differentially expressed genes in the blood of transplant recipients to identify patients who are likely to be adequately immunosuppressed and, in doing so, rule out graft damage. TruGraf measures the difference in gene expression for a precise panel of specific genes that have been empirically determined to discriminate between allografts that are truly healthy (Non-ACR), and those in transplant patients that have acute rejection on biopsy (AR). Nevertheless, the exact etiology of graft damage may be difficult to discern for the transplant clinician. The clinical characteristics and history of the liver transplant recipient as well as liver enzyme patterns can provide a pre-test probability of one diagnosis being more likely than the other (Acute cellular rejection, NASH, biliary or viral disease). The proposed tool will leverage our expertise in Machine Learning tools applied to clinical and molecular data (TruGraf assay results) to enable effective clinical implementation of the TruGraf assay.

Conditions

Acute Graft Rejection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Liver Transplant patient will be undergoing liver graft biopsy.

Liver transplant patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent.

TruGraf liver gene expression

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Transplant Genomics, Inc.

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mamatha Bhat, MD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

Toronto General Hospital -UHN

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sameera Rizvi

Role: CONTACT

sameera.rizvi@uhn.ca

4163404800 ext. 4878

Facility Contacts

Sameera Rizvi

Role: primary

sameera.rizvi@uhn.ca

416-340-4800 ext. 4878

Other Identifiers

24-5056

Identifier Type: -

Identifier Source: org_study_id