New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

NCT06097936 | Unknown

• 1 other identifier: RS1443/20(2442)
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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)

Keywords

HPV 16; oropharyngeal tumors (OPC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

HPV Patients

Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER

Interventions

HPV-ASSOCIATED OROPHARYNGEAL CANCER DIAGNOSTIC_TEST

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.

HPV Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male subjects
• age \> 18 years
• current and/or former smokers
• reporting at least 5 (Souza 2017) lifetime oral sex partners
• Written informed consent

You may not qualify if:

• Oral pathology
• inability to understand and sign an informed consent form

Sponsors & Collaborators

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

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: October 24, 2023
• Study Start: March 15, 2021
• Primary Completion: December 13, 2022
• Study Completion: April 1, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-06

Locations

IT (1)