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

Not Applicable

Recruiting

• Conditions: Donors; Organ Donor; Organ Transplants

• Registration Number: NCT06734091
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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 Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of intraoperative histological analysis	Up to 20 months	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

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy