Molecular-Based Selection of Patients with Head and Neck Squamous Cell Carcinoma: Biomarker Analysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recurrent/metastatic disease
Presence of a synchronous second tumor
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biomarkers evaluation
Other interventionEvaluate the prognostic role of the markers TP53, P16, Cyclin D1, EGFR, Akt, PDL-1, ERCC1 examined on biopsy samples.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Group A: Patients undergoing surgery followed by chemo-radiotherapy1 intervention
Group B: Group B: Patients undergoing exclusive chemo-radiotherapy with CDDP, CBDCA, or Cetuximab1 intervention
Trial outcomes
Primary outcomes
1
Percentage of P53 Expression in Tumor Tissue in Groups A and B
Time frame
84 monthsSecondary outcomes
1
Overall Survival (OS)
Describe the Overall Survival (OS) outcomes obtained in both Groups under observation.
Time frame
84 monhts2
Association between Overall Survival (OS) and the expression of biomarkers
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.
Time frame
84 monhtsSponsors and contacts
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Source ClinicalTrials.gov