NCT06905145

Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 128 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Locally Advanced Stage

Interventions

Type	Name	Description
OTHER	Biomarkers evaluation	Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.

Timeline

• Start date: 2024-05-03
• Primary completion: 2026-05-01
• Completion: 2032-05-01
• First posted: 2025-04-01
• Last updated: 2025-04-01

Locations

1 site across 1 country: Italy