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

NCT06905145 | Recruiting

• 1 other identifier: MATEs
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Locally Advanced Stage

Outcome Measures

Primary Outcomes (1)

• Percentage of P53 Expression in Tumor Tissue in Groups A and B

  84 months

Secondary Outcomes (2)

• Overall Survival (OS)

  84 monhts

• Association between Overall Survival (OS) and the expression of biomarkers

  84 monhts

Study Arms (2)

Group A: Patients undergoing surgery followed by chemo-radiotherapy

Other: Biomarkers evaluation

Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab

Other: Biomarkers evaluation

Interventions

Biomarkers evaluation OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Francesco Perri, MD

  IRCCS I.N.T. "G. Pascale"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Perri, MD

CONTACT

08117770403; f.perri@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 1, 2025
• Study Start: May 3, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

IT (1)