New Prognostic and Predictive Biomarkers for 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.

Study Overview

• Status: 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)
• Intervention / Treatment: Diagnostic test: HPV-ASSOCIATED OROPHARYNGEAL CANCER

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Aldo Venuti, MD; Phone Number: ND; Email: aldo.venuti@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The control group will be enlisted from among the subjects referred to the IRE outpatient clinic and/or the outpatient clinics of the LILT Provincial Committees collaborating with the Project to undergo a screening/checkup visit.

Samples will be collected in a mouthwash (i.e., Listerine) and stored in suitable solution to preserve nucleic acids (i.e., PreservCyt Transport Medium) and sent by courier from the peripheral centers to the IFOs where they will be appropriately analyzed.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

HPV Patients

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: University of California, San Diego; Lega Italiana per la Lotta contro i Tumori

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): December 13, 2022
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: HPV 16; oropharyngeal tumors (OPC)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Oropharyngeal Neoplasms
• Other Study ID Numbers: RS1443/20(2442)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No