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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Drugs / interventions | Cetuximab |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | May 3, 2024 |
| Main results expected | May 2026 |
| Study ends | May 2032 |
| Registry record updated | April 1, 2025 |
| Trial ID | NCT06905145 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
- Principal investigator: Francesco Perri, MD — IRCCS I.N.T. "G. Pascale"
- Study coordinator: Francesco Perri, MD
- Email: f.perri@istitutotumori.na.it
- Phone: 08117770403
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer
This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.
-
ICG with near-infrared imaging to visualize head and neck cancer during surgery
This study tests whether first-window indocyanine green fluorescence seen during surgery matches the cancer extent seen on pathology in patients with head and neck squamous cell carcinoma.
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ABBV-253 in adults with advanced solid tumors
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
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Online Sharing for Head & Neck Cancer Support
A mobile app designed for adults with head and neck cancer undergoing radiotherapy to see if daily social sharing and peer interaction can help reduce psychological distress.
-
Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer
This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.
-
Mild heat therapy added to standard treatment for locally advanced head and neck cancer
This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.