Clinical trial NCT06905145: Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
Official title: Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Squamous Cell Carcinoma
Locally Advanced Stage
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with locally advanced Head and Neck Squamous Cell Carcinoma who will have a biopsy sample obtained according to clinical practice. These groups will be divided based on the treatment received:

* \*\*Group A\*\*: Patients undergoing surgery followed by chemo-radiotherapy
* \*\*Group B\*\*: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab

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.

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

Primary outcomes:
measure: Percentage of P53 Expression in Tumor Tissue in Groups A and B
timeFrame: 84 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 84 monhts
measure: Association between Overall Survival (OS) and the expression of biomarkers
timeFrame: 84 monhts
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori | "Fondazione Pascale"
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Francesco Perri, MD
role: PRINCIPAL_INVESTIGATOR
References: