RecruitingNot ApplicableNCT06734091

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

80 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Organ donors (legally dead by brain or cardiac death) with suspected neoplasia.
  • Sending organs/tissues of all types and locations for extemporaneous examination request

Exclusion Criteria1

  • None

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Interventions

DIAGNOSTIC_TESTPrestoCHILL

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).


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT06734091