| Registry | NCT06718153 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 100 (Estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other) |
| Conditions | Hepatic Cancer, Hepatic Resection |
| Interventions | Immunohistochemistry and in situ hybridisation analysis (Diagnostic test) |
| Dates | start 2024-10-23, primary completion 2025-05-13 (estimated), completion 2025-06-01 (estimated), first posted 2024-12-05, last updated 2024-12-05 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Hepatic Cancer All trials for Hepatic Resection All trials of Immunohistochemistry and in situ hybridisation analysis
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.
The primary aim is the 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.
The secondary objective is the identification of possible associations between the presence of biomarkers Glutamin Synthetase, Glypican-3 and HSP70 and genetic mutations identified by clinical practice, in patients undergoing hepatic resection of HCC.
STUDY DESIGN: exploratory study. It is planned to recruit approximately 100 patients, who underwent liver resection for HCC and already underwent NGS analysis (for which the mutational profile is already known). All clinical and histological data will be collected, immunohistochemistry investigations will be performed on formalin-fixed and paraffin-embedded material corresponding to that used for molecular analysis.
STUDY POPULATION: The study envisages the enrolment of 100 patients, already undergoing liver resection for HCC at the IRCCS AOU of Bologna, in the period 2020-2022, who will be retrospectively re-evaluated.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Resected HCC patients | Experimental | Diagnostic Test: Immunohistochemistry and in situ hybridisation analysis | patients resected for HCC with NGS data, and paraffin material for immunohistochemistry analysis. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥18 years * Patients resected for HCC * Availability of NGS data * Availability of paraffin material for immunohistochemistry investigations Exclusion Criteria: * None
| Facility | City | Country | Status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Italy | Recruiting |