RecruitingNCT06905145

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


Sponsor

National Cancer Institute, Naples

Enrollment

128 participants

Start Date

May 3, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Patients aged \> 18 years
  • Written informed consent approved by the competent Independent Ethics Committee
  • 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
  • Locally advanced stage: from T1N1M0 to T4N3M0
  • Availability of a tissue sample from a biopsy performed according to clinical practice guidelines.

Exclusion Criteria2

  • Recurrent/metastatic disease
  • Presence of a synchronous second tumor

Interventions

OTHERBiomarkers evaluation

Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.


Locations(1)

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, Italy

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NCT06905145


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