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

NCT06734013 | Recruiting

• 2 other identifiers: OLTpanel_20242023.0189
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rejection; Transplant, Liver

Keywords

Liver transplant

Outcome Measures

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

  At the time of biopsy, up to 6 months

Secondary Outcomes (2)

• Identification of genes associated with the diagnosis of acute humoral rejection

  At the time of biopsy, up to 6 months

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

  At the time of biopsy, up to 6 months

Study Arms (1)

Patients with post-OLT rejection

EXPERIMENTAL

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

Diagnostic Test: Molecular diagnostic

Interventions

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

Patients with post-OLT rejection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Molecular Diagnostic Techniques

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques

Study Officials

• Deborah Malvi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Malvi, MD

CONTACT

0512143761; deborah.malvi@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 16, 2024
• Study Start: October 17, 2024
• Primary Completion: May 2, 2025
• Study Completion: June 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)