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

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

Study Overview

• Status: Recruiting
• Conditions: Donors; Organ Donor; Organ Transplants
• Intervention / Treatment: Diagnostic test: PrestoCHILL

Detailed Description

Optimisation of frozen material can be achieved with specific tools that improve the quality of freezing and the cutting of histological sections, allowing a lower incidence of artefacts, with better histological definition. These instruments would also allow the execution of automated IHC protocols, with increased diagnostic sensitivity and specificity and better risk stratification for donors with malignancy. All this should lead to an increase in the donor pool with better oncological risk stratification and, consequently, increase the number of organs to be allocated, making it possible to respond more promptly to the great demand for organs needed for transplantation.

Moreover, not only would the certain exclusion of a neoplasm allow the use of donors who would otherwise have been considered to be at unacceptable risk and therefore excluded from the donor process, but a more precise diagnosis of the neoplasm (where present) would allow the second opinion to stratify the risk more accurately, with a more rational use of organs.

All organ donors who request extemporaneous intraoperative examinations to define the oncological risk of donation during the study period will be recruited.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah Malvi, MD; Phone Number: 0512143761; Email: deborah.malvi@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Deborah Malvi, MD; Phone Number: 0512143761; Email: deborah.malvi@aosp.bo.it
    • Principal Investigator: Deborah Malvi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Donors undergoing intraoperative examination; Donors undergoing intraoperative extemporaneous examination to define the oncological risk of donation during the study period

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of intraoperative histological analysis	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. Increase in the number of donors used and the number of grafts (liver and kidneys, but also heart, lungs and 'bankable' tissues such as bones, vascular segments and corneas) that could be recovered and then used for transplantation due to better risk stratification of donors with malignancy	Up to 20 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Deborah Malvi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Transplants
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: donorEXT_2022; RC 2022-2024 (Other Grant/Funding Number: Ministero della Salute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No