RecruitingNot ApplicableNCT06718153

Immunohistochemical Algorithm for the Diagnosis and Classification of Hepatocellular Carcinomas With TERT, TP53 and CTNNB1 Mutation


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

100 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The presence of certain mutations in HCC, such as TERT and TP53, have a suspected or proven prognostic role in resected patients, but lack a morphological or immunophenotypic counterpart, which would allow us to define which tumours are rationally candidate for molecular biology analysis. The identification of a histological and immunohistochemical algorithm to determine which HCCs to take to NGS for prognostic purposes will save time and economic costs in the laboratory by rationalising available resources. In the future, the application of the immunohistochemical and molecular algorithm on biopsy could allow better prognosis and predictivity even before surgery/therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a new lab-based method to diagnose and classify liver cancer (hepatocellular carcinoma, or HCC) based on specific gene mutations. Researchers are looking at tissue samples from patients who have already had surgery to see if certain protein markers in the tissue match up with known genetic changes in the tumor. **You may be eligible if...** - You are 18 years or older - You have had surgery to remove liver cancer (HCC) - Your cancer was tested with genetic sequencing (NGS data is available) - Tissue samples from your surgery are available for further lab analysis **You may NOT be eligible if...** - There are no stated exclusion criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTImmunohistochemistry and in situ hybridisation analysis

immunohistochemistry and in situ hybridisation analysis for several markers, including p53, beta-Catenin and albumin, but also markers considered diagnostic for HCC such as Glutamin Synthetase, Glypican-3 and HSP70, to identify a more rational diagnostic-prognostic algorithm for primary liver lesions.


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT06718153


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