Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francesco Perri, MD
- Phone Number: 08117770403
- Email: f.perri@istitutotumori.na.it
Study Locations
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Napoli, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori | "Fondazione Pascale"
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Contact:
- Francesco MD Perri
- Phone Number: 0117770403
- Email: f.perri@istitutumori.na.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A: Patients undergoing surgery followed by chemo-radiotherapy
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Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.
|
|
Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab
|
Evaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of P53 Expression in Tumor Tissue in Groups A and B
Time Frame: 84 months
|
84 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: 84 monhts
|
Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.
|
84 monhts
|
|
Association between Overall Survival (OS) and the expression of biomarkers
Time Frame: 84 monhts
|
Define the association between Overall Survival (OS) and the expression of biomarkers (TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1) in both Groups under observation.
|
84 monhts
|
Collaborators and Investigators
Investigators
- Principal Investigator: Francesco Perri, MD, IRCCS I.N.T. "G. Pascale"
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MATEs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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