Acute Graft RejectionNCT06557564
Diagnosis of Graft Pathology by TruGraf
An observational study of Acute Graft Rejection, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Rejection
- What is being tested?
- TruGraf liver gene expression
- How many people
- 471 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2024to 30 Dec 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant patient with graft pathology
Who may be able to join
- . 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital -UHN
Toronto, Ontario, M5G 2N2
Sameera Rizvi, 416-340-4800 ext. 4878, sameera.rizvi@uhn.ca
Mamatha Bhat, MD
About this study
Official title: Development of a Machine Learning Tool for Non-invasive Diagnosis of Liver Graft Pathology Using TruGraf
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.
Read the 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
- Being tested
- TruGraf liver gene expression
- Keywords
- Liver transplant patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruGraf liver gene expressionGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: TruGraf liver gene expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (1)
Identify specific etiologies of ongoing graft damage
Identify specific etiologies of ongoing graft damage by examining TruGraf gene expression array.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start20 Jul 2024
- Primary completion20 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft RejectionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 471 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Responsible party
- Sponsor
- Investigators
- Mamatha Bhat, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557564
- Sponsor's protocol ID
- 24-5056
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected from EPIC by UHN study team. Patient information will be de-identified, and each participant will be identified by a unique study number. The study investigators and UHN Ethics Board may access all PHI being collected for this study for audit/inspection purposes.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Machine Learning Tool for Non-invasive Diagnosis of Liver Graft Pathology Using TruGraf
- ClinicalTrials.gov ID
- NCT06557564
- Acronym / sponsor ID
- 24-5056
- Conditions
- Acute Graft Rejection
- Keywords
- Liver transplant patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 471 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Transplant Genomics, Inc.
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant patient will be undergoing liver graft biopsy. | – | Genetic: TruGraf liver gene expressionLiver transplant patients will be undergoing liver graft biopsy (for any reason), or have had a liver biopsy within 48 hours of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant patient with graft pathology
Key inclusion criteria (4 listed)
- . 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruGraf liver gene expressionBlood 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. | Genetic | Liver Transplant patient will be undergoing liver graft biopsy. |
Primary outcome
Develop and validate a ML-based algorithm
Time frame: 36 months
Develop and validate a ML-based algorithm that identifies major graft pathologies using liver biopsy as the reference method.
1 secondary outcome
Identify specific etiologies of ongoing graft damage
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Yes. Data will be collected from EPIC by UHN study team. Patient information will be de-identified, and each participant will be identified by a unique study number. The study investigators and UHN Ethics Board may access all PHI being collected for this study for audit/inspection purposes.
Related trials for Acute Graft Rejection
RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingEarly Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Hematologic Malignancy, Bone Marrow Transplant Rejection
Active, not recruitingObservational study
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Rejection Acute Renal, Rejection Chronic Renal
RecruitingPhase 3
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
RecruitingObservational study
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
Acute Rejection of Renal Transplant, Graft Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mamatha Bhat, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Graft Rejection, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sameera Rizvi (4163404800 ext. 4878, sameera.rizvi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop and validate a ML-based algorithm (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.