Improving diagnosis time for organ donors with suspected cancer
Rapid Processing and Immunohistochemistry Method for Optimising Diagnosis Time in Solid Organ Donors With Suspected Malignancy
This study is testing a new way to quickly and accurately check for cancer in organ donors to help more people get transplants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06734091 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of standard histological analysis methods with an experimental approach that optimizes sample freezing and utilizes a rapid immunohistochemistry (IHC) procedure. By enhancing the quality of frozen tissue samples and automating IHC protocols, the study aims to improve diagnostic sensitivity and specificity for organ donors with suspected malignancies. The goal is to increase the donor pool by accurately assessing oncological risks, allowing for more organs to be allocated for transplantation. Organ donors requiring intraoperative examinations will be recruited for this study.
Who should consider this trial
Good fit: Ideal candidates for this study are organ donors who are legally declared dead and have suspected neoplasia.
Not a fit: Patients who do not have suspected malignancies or are not organ donors will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the number of viable organ donors by providing quicker and more accurate diagnoses.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic processes in organ transplantation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Deborah Malvi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Deborah Malvi, MD
- Email: deborah.malvi@aosp.bo.it
- Phone: 0512143761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.