This is an observational, prospective study enrolling patients who meet the inclusion criteria and provide consent for the use of biopsy samples collected as part of standard clinical practice. The analysis will focus on the following biomarkers: TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1. These biomarkers will be examined in both observation groups.
The primary objective of this project is to evaluate the prognostic role of the biomarker P53, as numerous studies suggest its association with poor prognosis. This analysis will be particularly relevant for p16-positive (HPV-related) patients, who are currently considered a good prognosis category. The study aims to determine whether cases with overexpression of both p16 and P53 deviate from this assumption. A secondary objective is to validate a molecular signature in clinical practice, composed of multiple biomarkers, to assess whether specific combinations can predict treatment response. The biomarkers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, and ERCC1 will be analyzed on biopsy samples from patients with newly diagnosed, locally advanced squamous cell carcinoma of the head and neck. The study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who have an available biopsy sample collected as part of standard clinical practice. The groups will be classified based on the treatment received: * Group A: Patients undergoing surgery followed by chemoradiotherapy. * Group B: Patients receiving exclusive chemoradiotherapy with CDDP, CBDCA, or Cetuximab.
Study Type
OBSERVATIONAL
Enrollment
128
Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, Italy
RECRUITINGPercentage of P53 Expression in Tumor Tissue in Groups A and B
Time frame: 84 months
Overall Survival (OS)
Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.
Time frame: 84 monhts
Association between Overall Survival (OS) and the expression of biomarkers
Define the association between Overall Survival (OS) and the expression of biomarkers (TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1) in both Groups under observation.
Time frame: 84 monhts
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