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

NCT06718153 | Recruiting

• 2 other identifiers: HCCimmuno_20242023.0275
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Molecular diagnostics; Immunohistochemistry

Outcome Measures

Primary Outcomes (1)

• associations between p53 and beta-Catenin and the presence of the genetic mutations

  Identification of associations between the biomarkers p53 and beta-Catenin and the presence of the genetic mutations TERT, TP53 and CTNNB1 identified by clinical practice, in patients undergoing hepatic resection of HCC.

  At baseline

Secondary Outcomes (1)

• Identification of associations between the presence of biomarkers Glutamin Synthetase, Glypican-3 and HSP70 and genetic mutations

  At baseline

Study Arms (1)

Resected HCC patients

EXPERIMENTAL

patients resected for HCC with NGS data, and paraffin material for immunohistochemistry analysis.

Diagnostic Test: Immunohistochemistry and in situ hybridisation analysis

Interventions

Immunohistochemistry and in situ hybridisation analysis DIAGNOSTIC_TEST

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.

Resected HCC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients resected for HCC
• Availability of NGS data
• Availability of paraffin material for immunohistochemistry investigations

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Francesco Vasuri, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francecso Vasuri, MD

CONTACT

0512143761; francesco.vasuri2@unibo.it

Deborah Malvi, MD

CONTACT

0512143761; deborah.malvi@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic identification of possible associations between the biomarkers p53 and beta-Catenin and the presence of the genetic mutations TERT, TP53 and CTNNB1 identified by clinical practice, in patients undergoing hepatic resection of HCC

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: October 23, 2024
• Primary Completion: May 13, 2025
• Study Completion: June 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)