Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, HPV 16 Positive Oropharyngeal Tumors (OPC), PREDICTIVE BIOMARKERS
Conditions
Keywords
HPV 16, oropharyngeal tumors (OPC)
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.
Interventions
DIAGNOSTIC_TESTHPV-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.
Sponsors
Regina Elena Cancer Institute
University of California, San Diego
Lega Italiana per la Lotta contro i Tumori
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed