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

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Locally Advanced Stage

• Registration Number: NCT06905145
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Study Timeline

• Study Start: 2024-05-03
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-05
• Study Completion: 2032-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Patients aged > 18 years
2. Written informed consent approved by the competent Independent Ethics Committee
3. Histopathological diagnosis of squamous cell carcinoma of the head and neck region originating from one of the following organs or structures: Oral cavity, oropharynx, larynx, hypopharynx
4. Locally advanced stage: from T1N1M0 to T4N3M0
5. Availability of a tissue sample from a biopsy performed according to clinical practice guidelines.

Exclusion Criteria

1. Recurrent/metastatic disease
2. Presence of a synchronous second tumor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of P53 Expression in Tumor Tissue in Groups A and B	84 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	84 monhts	Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.
Association between Overall Survival (OS) and the expression of biomarkers	84 monhts	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.

Trial Locations

Locations (1)

Istituto Nazionale Tumori | "Fondazione Pascale"; 🇮🇹 Napoli, Italy