Clinical trial · Observational
New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC | — | UNRESOLVED | — |
| HPV 16 Positive Oropharyngeal Tumors (OPC) | — | UNRESOLVED | — |
| PREDICTIVE BIOMARKERS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV-ASSOCIATED OROPHARYNGEAL CANCER | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HPV Patients
- interventionNames
- Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER
Primary outcomes (1)
- measure
- Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
- timeFrame
- Sample collection period: 6 months Total duration of the study: 12 months
- description
- 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 outcomes (1)
- measure
- Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available