Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The possibility of introducing molecular diagnostics in support of histological and clinical diagnostics (still not routinely applied today but recommended by the most recent guidelines) will result in faster and more precise diagnostics, capable of highlighting early activation of cellular signals related to rejection in the absence yet of a frank clinical and histological picture. This will lead to a better diagnostic stratification of these patients, with the possibility of rationalising the choice of therapy.
AIMS: The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients. To this end, a panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from published results in the literature and applied to biological material derived from biopsies. The secodnary objective is to identify genes associated with the diagnosis of humoral acute rejection and those associated with the diagnosis of cell-mediated acute rejection.
ENDPOINT/S: diagnostic (No of cases) of acute rejection; possible specific diagnosis of acute cell-mediated and humoral rejection.
STUDY DESIGN: The study is single-centre, observational, tissue-based, cross-sectional, exploratory, retrospective and prospective. Approximately 40 patients are expected to be enrolled, 20 retrospective and 20 prospective. All patients will be treated according to clinical practice: clinical and histological data will be collected in pseudonymous form. Routine histological and immunohistochemical investigations as well as RT-PCR analysis will be performed on the biopsy tissue (FFPE material). To assess the diagnostic sensitivity with regard to rejection status, and for panel development, a retrospective cohort of consecutive cases with acute rejection will be enrolled; for the prospective cohort, consecutive patients requiring liver biopsy for diagnostic indications will be enrolled.
STUDY POPULATION: The study will enrol patients undergoing OLT who require a liver biopsy for diagnostic indications. There is no restriction of sex or underlying pathology. Retrospective case enrolment is planned within the first 6 months of 2024. Prospective case enrolment will take place during 2024. Patients will be enrolled at the U.O. of Internal Medicine for the Treatment of Severe Organ Failures, IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, where the biopsy will be performed as standard of care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deborah Malvi, MD
- Phone Number: 0512143761
- Email: deborah.malvi@aosp.bo.it
Study Locations
-
-
-
Bologna, Italy, 40138
- Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
Contact:
- Deborah Malvi, MD
- Phone Number: 0512143761
- Email: deborah.malvi@aosp.bo.it
-
Principal Investigator:
- Deborah Malvi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with a diagnosis of post-OLT rejection prior to the visit at which they will be enrolled, with tissue available for RT-PCR investigations
- Age ≥ 18 years
- Informed consent
Exclusion Criteria:
- Age <18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with post-OLT rejection
The patient will be enrolled in a single visit, as per standard of care, clinical and general data will be collected and the biopsy will be performed
|
RNA will be analysed using a Real-Time PCR expression card (TaqMan Real-Time PCR assay technology - Thermo Fisher Scientific).
The analysis will be performed using a Real-Time Light Cycler 480 (Roche).
The expression card will be customised for the study, including the genes cxcl9/10, cav-1, rhoj, cdh5, cd96, tnfsf8, il-21r, vcam, klrk1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of genes associated with acute rejection liver transplant.
Time Frame: At the time of biopsy, up to 6 months
|
A panel of acute rejection indicator genes (both humoral and cell-mediated) will be selected from Scientific literature and applied to biological material from biopsies
|
At the time of biopsy, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of genes associated with the diagnosis of acute humoral rejection
Time Frame: At the time of biopsy, up to 6 months
|
A panel of acute rejection indicator genes applied to biological material from biopsies
|
At the time of biopsy, up to 6 months
|
|
Identification of genes associated with the diagnosis of acute cell-mediated rejection
Time Frame: At the time of biopsy, up to 6 months
|
A panel of acute rejection indicator genes applied to biological material from biopsies
|
At the time of biopsy, up to 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Deborah Malvi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OLTpanel_2024
- 2023.0189 (Other Grant/Funding Number: Fondazione Cassa di Risparmio in Bologna)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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