Diagnosis of Graft Pathology by TruGraf

NCT06557564 | Recruiting

• 1 other identifier: 24-5056
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

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

Keywords

Liver transplant patients

Outcome Measures

Primary Outcomes (1)

• Develop and validate a ML-based algorithm

  Develop and validate a ML-based algorithm that identifies major graft pathologies using liver biopsy as the reference method.

  36 months

Secondary Outcomes (1)

• Identify specific etiologies of ongoing graft damage

  36 months

Study Arms (1)

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.

Genetic: TruGraf liver gene expression

Interventions

TruGraf liver gene expression 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.

Liver Transplant patient will be undergoing liver graft biopsy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver transplant patient with graft pathology

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Transplant Genomics, Inc.: collaborator

Study Sites (1)

Toronto General Hospital -UHN

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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).

Study Officials

• Mamatha Bhat, MD

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameera Rizvi

CONTACT

4163404800; sameera.rizvi@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: July 20, 2024
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 36 months
• Access Criteria: At the time of publication, data generated and analyzed as part of this study, including de-identified datasets and gene expression, will be made available in appropriate community-endorsed, public repositories and/or databases. In particular, gene expression data, and the corresponding sex, age, and disease type of each sample will be made available in open-access or controlled-access platforms. This access is subject to restrictions that may be imposed via existing collaboration agreements. No identifiers will leave UHN.

Locations

CA (1)