Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biomarkers evaluation.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma, Locally Advanced Stage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Biomarkers evaluation
Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.
Primary outcome measures
- Percentage of P53 Expression in Tumor Tissue in Groups A and B [Time frame: 84 months]
Secondary outcome measures (2)
- Overall Survival (OS) [Time frame: 84 monhts]
- Association between Overall Survival (OS) and the expression of biomarkers [Time frame: 84 monhts]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Recurrent/metastatic disease
- Presence of a synchronous second tumor
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Nazionale Tumori | "Fondazione Pascale" — Naples
Identifiers
NCT: NCT06905145 · MATEs