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NCT Number: NCT06717542

Tissue Analysis of Liver Grafts as a Predictor of Transplant Outcome.

Despite the good clinical results in terms of outcome with the application of HOPE prior to liver transplantation, very little is still known about the phenotypic and molecular changes that occur during perfusion/preservation during HOPE, particularly with regard to endothelial trophism and activation. Delving into these aspects would be very useful to allow personalised perfusion treatments in the future, thus improving the outcome of transplantation.

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Key information

Conditions

Hepatic Transplantation Behavior Rejection, Psychology Rejection; Transplant, Liver Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Francesco Vasuri, MD

CONTACT

[email protected]

0512143761

Francesco Vasuri, MD

PRINCIPAL_INVESTIGATOR

About this study

The primary aim of the study is the identification of specific 'endothelial signatures' (markers on tissue with immunohistochemistry and gene expression with RT-PCR) in liver grafts after HOPE treatment, predictive of transplant outcome. Interventional study without drug, including two cohorts of patients: (1) liver donors, on whom an allocation biopsy for organ quality will be performed (as standard of care); (2) liver recipients (from donors in cohort 1) on whom a study-specific biopsy will be performed as soon as the transplant has taken place (after vascular anastomoses with organ revascularisation). The study-specific biopsy constitutes the intervention of the study; patients will be treated according to the judgement of the physician and the information reported in the Technical Data Sheet of each product of any concomitant therapies administered according to clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For Donors:

Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.

  • HOPE performed on the liver graft prior to transplantation.
  • For Recipients:
  • Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
  • Age greater than/equal to 18 years.

Exclusion criteria

  • None

Treatment and study plan

histochemical and immunohistochemical analysis

Diagnostic Test

2 µm sections will be cut from the paraffin blocks for histochemical and immunohistochemical (IHC) investigations. IHC will be performed with an automated stainer (Ventana/Roche®, Ventana Medical Systems, USA) for the endothelial markers CD34, ERG, Nestin and Caveolin-1

RT-PCR

Diagnostic Test

Custom RT-PCR analyses will be performed manually for the transcripts (mRNA) of the ERG, Nestin, VEGFR and other genes, at the Pathology Anatomy lab hall. 18 (Prof. D'Errico). Total RNA will be extracted from the paraffin blocks with the RecoverAll™ Total Nucleic Acid Isolation kit (Invitrogen). Reverse Transcriptase will be performed with the High Capacity Reverse Transcription kit (Life Technologies), using the specific primers. Real-Time PCR will be performed with the CFX Connect Real-Time PCR Identification System (BioRad).

Primary outcomes

  1. Identification of specific '"endothelial signatures"

    Time frame: Within 24 months

    Main outcomes to assess the outcome of transplantation will be the percentage of early (PNF and EAD, within 1 week after transplantation) and late (rejection and complications) complications, as well as mortality among recipients within 24 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Malvi, MD

CONTACT

[email protected]

0512143761

Francecso Vasuri, MD

CONTACT

[email protected]

0512143761

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Tissue Analysis (Histological, Ultrastructural and Molecular) of Liver Grafts as a Predictor of Transplant Outcome.

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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