Clinical trial Recruiting at 1 site Observational Ages 18 and up

Biomarker analysis for patients with advanced head and neck cancer

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

Run by National Cancer Institute, Naples · NCT06905145 · Data updated 2026-11-12

This study is testing if certain biomarkers in biopsy samples can help predict how well patients with advanced head and neck cancer will respond to their treatment.

More Head and Neck Squamous Cell Carcinoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment128 (estimated)
SponsorNational Cancer Institute, Naples
Academic / other
Drugs / interventionsCetuximab
Locations1 site (Naples)
StatusRecruiting
StartedMay 3, 2024
Main results expectedMay 2026
Study endsMay 2032
Registry record updatedApril 1, 2025
Trial IDNCT06905145 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with newly diagnosed, locally advanced head and neck squamous cell carcinoma who have available biopsy samples.

Probably not a fit

Patients with recurrent or metastatic disease or those with a synchronous second tumor may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the prognostic role of various biomarkers, including TP53 and P16, in patients with locally advanced head and neck squamous cell carcinoma. It will analyze biopsy samples collected during standard clinical practice to determine if specific biomarker combinations can predict treatment response. The study will classify patients based on their treatment regimens, either surgery followed by chemoradiotherapy or exclusive chemoradiotherapy. The goal is to validate a molecular signature that could enhance clinical decision-making.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with head and neck cancer based on their biomarker profiles.

How similar studies have gone: Other studies have shown promise in using biomarker analysis for prognostic evaluation in head and neck cancers, suggesting this approach is both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Istituto Nazionale Tumori | "Fondazione Pascale"
    Naples, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.