Recruiting

TruGraf

Sponsor:

University Health Network, Toronto

Code:

NCT06557564

Conditions

Acute Graft Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TruGraf liver gene expression

Study Details

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.

Conditions

Acute Graft Rejection

Study ID

NCT06557564

Start date

Jul 20, 2024

Status verified date

Jun, 2024

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jul 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

471 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Develop and validate a ML-based algorithm [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Sameera Rizvi

4163404800sameera.rizvi@uhn.ca

Locations

Toronto General Hospital -UHN

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Sameera Rizvi

416-340-4800sameera.rizvi@uhn.ca

Principal Investigator:

Mamatha Bhat, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 16, 2024

Last verified

Jun, 2024

Keywords

  • Liver transplant patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-08-16.