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Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation

NCT ID: NCT06734013

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2025-06-30

Brief Summary

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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 results published 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.

Detailed Description

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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.

Conditions

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Rejection; Transplant, Liver

Keywords

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Liver transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Molecular diagnostic

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Molecular diagnostic

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Malvi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Deborah Malvi, MD

Role: CONTACT

Phone: 0512143761

Email: [email protected]

Facility Contacts

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Deborah Malvi, MD

Role: primary

Other Identifiers

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2023.0189

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OLTpanel_2024

Identifier Type: -

Identifier Source: org_study_id