NCT06097936

New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV-ASSOCIATED OROPHARYNGEAL CANCER	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.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-12-13
• Completion: 2024-04-01
• First posted: 2023-10-24
• Last updated: 2023-10-24

Locations

1 site across 1 country: Italy