Algorithm for diagnosing liver cancer mutations
Immunohistochemical Algorithm for the Diagnosis and Classification of Hepatocellular Carcinomas With TERT, TP53 and CTNNB1 Mutation
NA · IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06718153
This study is testing a new way to identify specific mutations in liver cancer to help doctors make better treatment decisions for patients before surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06718153 on ClinicalTrials.gov |
What this trial studies
This study aims to develop an immunohistochemical algorithm to identify specific mutations in hepatocellular carcinoma (HCC) that could guide molecular analysis for prognostic purposes. By examining the associations between biomarkers and genetic mutations in patients who have undergone liver resection, the study seeks to streamline laboratory resources and improve patient outcomes. Approximately 100 patients with known mutational profiles will be retrospectively evaluated using formalin-fixed and paraffin-embedded samples. The goal is to enhance the predictive capabilities of biopsies prior to surgery or therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone liver resection for hepatocellular carcinoma and have available next-generation sequencing data.
Not a fit: Patients who have not undergone liver resection or lack available NGS data may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate prognostic assessments and tailored treatments for patients with liver cancer.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in using molecular diagnostics for cancer prognosis, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Patients resected for HCC * Availability of NGS data * Availability of paraffin material for immunohistochemistry investigations Exclusion Criteria: * None
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Francesco Vasuri, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Francecso Vasuri, MD
- Email: francesco.vasuri2@unibo.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.
Conditions: Hepatic Cancer, Hepatic Resection, Molecular diagnostics, Immunohistochemistry