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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years

Trial design

Design model

Single group

Treatments tested in this trial

  • Molecular diagnostic

    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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients with post-OLT rejectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Identification of genes associated with acute rejection liver transplant.

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

Time frame
At the time of biopsy, up to 6 months

Secondary outcomes

1

Identification of genes associated with the diagnosis of acute humoral rejection

A panel of acute rejection indicator genes applied to biological material from biopsies

Time frame
At the time of biopsy, up to 6 months
2

Identification of genes associated with the diagnosis of acute cell-mediated rejection

A panel of acute rejection indicator genes applied to biological material from biopsies

Time frame
At the time of biopsy, up to 6 months

Other outcomes

Sponsors and contacts

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