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

NCT06734091 | Recruiting

• 2 other identifiers: donorEXT_2022RC 2022-2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transplants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Donors undergoing intraoperative examination

EXPERIMENTAL

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

Diagnostic Test: PrestoCHILL

Interventions

PrestoCHILL DIAGNOSTIC_TEST

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).

Donors undergoing intraoperative examination

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

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

Model Details: Donors tissue will be send to Pathological Anatomy to perform intraoperative examination according to standard of care procedures and to perform intraoperative examination according to experimental methods (with possible immunohistochemistry).

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 16, 2024
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)