New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

Regina Elena Cancer Institute

Status: Enrolling

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

Treatments: Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER

Study type: Observational

Funder types: Other

Identifiers

NCT06097936

RS1443/20(2442)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 1 patient group

HPV Patients

Treatment:

Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER