New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

Study Overview
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Brief Summary
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The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV.

Official Title
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New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

Conditions
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PREDICTIVE BIOMARKERS, Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, HPV 16 Positive Oropharyngeal Tumors (OPC)

Intervention / Treatment
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* Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects age > 18 years current and/or former smokers reporting at least 5 (Souza 2017) lifetime oral sex partners Written informed consent Exclusion Criteria: Oral pathology inability to understand and sign an informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV Patients<br> | Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER<br>* The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples | The expected results concern the identification of OPC subgroups correlated with the expression of HPV16 E5.RNA will be extracted from FFPE with a commercial RNeasy kit (QIAGEN) and reverse transcribed into cDNA. The synthesized cDNA will be subjected to real-time PCR with specific primers, already designed by the Beacon Design software (BioRad) to include the splicing site (880-3358) of the specific E5 transcript. The relative amount of genes will be determined by the ΔΔCt method normalized to housekeeping genes. | Sample collection period: 6 months Total duration of the study: 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples | the primary outcome is necessary for a subsequent larger study in which the expression of E5 will be evaluated together with that of EGFR and HLA and associated with prognosis and different responses to therapy | Sample collection period: 6 months Total duration of the study: 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV 16, oropharyngeal tumors (OPC)