New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

PREDICTIVE BIOMARKERS Clinical Trial

Official title:

New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097936
• Other study ID #: RS1443/20(2442)
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2023
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2024
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• PREDICTIVE BIOMARKERS

Intervention

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.

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Lega Italiana per la Lotta contro i Tumori, University of California, San Diego

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ??Ct method normalized to housekeeping genes.	Sample collection period: 6 months Total duration of the study: 12 months
Secondary	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