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Recruiting NCT06905145

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

Trial Parameters

Condition Head and Neck Squamous Cell Carcinoma
Sponsor National Cancer Institute, Naples
Study Type OBSERVATIONAL
Phase N/A
Enrollment 128
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-03
Completion 2026-05
Interventions
Biomarkers evaluation

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.

Eligibility Criteria

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

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