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

NCT06718153 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • Hepatic Cancer
  • Hepatic Resection

Interventions

DIAGNOSTIC_TEST

Immunohistochemistry 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.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Francesco Vasuri, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2025-05-13
Completion
2025-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06718153 on ClinicalTrials.gov