New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

Recruiting

• 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: Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER

• Registration Number: NCT06097936
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Primary Completion: 2022-12-13
• Study First Submitted: 2023-03-28
• Status Verified: 2023-06
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HPV Patients	HPV-ASSOCIATED OROPHARYNGEAL CANCER	-

Primary Outcome Measures

Name	Time	Method
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples	Sample collection period: 6 months Total duration of the study: 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples	Sample collection period: 6 months Total duration of the study: 12 months	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

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy