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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| Lega Italiana per la Lotta contro i Tumori | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Regina Elena" National Cancer Institute | Recruiting | Rome | 00144 | Italy |
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