Recruiting

Diagnostic Algorithm for Hepatocellular Carcinomas with TERT, TP53, and CTNNB1 Mutations

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What is being tested

Immunohistochemistry and in situ hybridisation analysis

Diagnostic Test
Who is being recruted

Digestive System Diseases+3

+ Digestive System Neoplasms

+ Liver Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ContactFrancecso Vasuri, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 23, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding the relationship between certain biomarkers and genetic mutations in liver cancer, specifically hepatocellular carcinoma (HCC). Researchers are examining if there is a link between the biomarkers p53 and beta-Catenin and genetic mutations TERT, TP53, and CTNNB1 in patients who have had part of their liver removed due to cancer. The study also looks at other biomarkers like Glutamin Synthetase, Glypican-3, and HSP70 to see how they relate to these genetic mutations. This research is important because finding these associations could improve how liver cancer is diagnosed and classified, potentially leading to better treatment options for patients. Participants in this study include about 100 patients who have already undergone liver surgery for HCC and have had their genetic profiles analyzed. The researchers will use samples previously collected and preserved to perform new tests, specifically immunohistochemistry, to further investigate the presence of these biomarkers. This approach allows the study to leverage existing patient data to explore the genetic and biomarker connections without needing new surgeries or procedures. This study carries minimal risk as it uses previously collected samples, and it aims to provide valuable insights into liver cancer diagnosis.

Official TitleImmunohistochemical Algorithm for the Diagnosis and Classification of Hepatocellular Carcinomas With TERT, TP53 and CTNNB1 Mutation
NCT06718153
Principal SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ContactFrancecso Vasuri, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Site

Criteria

4 inclusion criteria required to participate
Age ≥18 years

Patients resected for HCC

Availability of NGS data

Availability of paraffin material for immunohistochemistry investigations

1 exclusion criteria prevent from participating
None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, ItalyOpen IRCCS Azienda Ospedaliero-Universitaria di Bologna in Google Maps
Recruiting
One Study Center