New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male subjects
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age > 18 years
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current and/or former smokers
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reporting at least 5 (Souza 2017) lifetime oral sex partners
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Written informed consent
Exclusion Criteria:
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Oral pathology
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inability to understand and sign an informed consent form
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | "Regina Elena" National Cancer Institute | Rome | Italy | 00144 |
Sponsors and Collaborators
- Regina Elena Cancer Institute
- University of California, San Diego
- Lega Italiana per la Lotta contro i Tumori
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RS1443/20(2442)