Biomarker analysis for patients with advanced head and neck cancer
Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Drugs / interventions | Cetuximab |
| Locations | 1 site (Naples) |
| Trial ID | NCT06905145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed, locally advanced head and neck squamous cell carcinoma who have available biopsy samples.
Not a fit: Patients with recurrent or metastatic disease or those with a synchronous second tumor may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Naples
- Istituto Nazionale Tumori | "Fondazione Pascale" — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Perri, MD — IRCCS I.N.T. "G. Pascale"
- Study coordinator: Francesco Perri, MD
- Email: f.perri@istitutotumori.na.it
- Phone: 08117770403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.