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Rapid Processing and Immunohistochemistry Method for Optimising Diagnosis Time in Solid Organ Donors, Suspected Malignancy

NCT06734091 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-16

No results posted yet for this study

Summary

Comparison of the diagnostic yield of intra-operative histological analysis of donor tissue with suspected neoplasia performed with the standard method versus the experimental method, which involves optimisation of sample freezing and analysis with the IHC fast track procedure

Conditions

  • Donors
  • Organ Donor
  • Organ Transplants

Interventions

DIAGNOSTIC_TEST

PrestoCHILL

PrestoCHILL (Milestone Medical Technologies, Inc.MI 49009, USA)which by reducing the tissue freezing time to less than 60 seconds should eliminate freezing artefacts and improve the quality of sections for morphological and IHC examination. In selected cases and according to the diagnostic algorithm required for the diagnosis of specific neoplasms, rapid IHC analysis will be performed with the Benchmark ULTRA® immunostainer (Ventana Medical Systems), which is already in place to confirm or exclude the suspected neoplasm, as well as to confirm the histotype. For the latter purpose, commercially available antibody panels for routine examinations will be used (Ventana/Roche,Ventana Medical Systems, USA).

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Deborah Malvi, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-03-31
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734091 on ClinicalTrials.gov