New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects
- •age > 18 years
- •current and/or former smokers
- •reporting at least 5 (Souza 2017) lifetime oral sex partners
- •Written informed consent
排除标准
- •Oral pathology
- •inability to understand and sign an informed consent form
结局指标
主要结局
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
时间窗: 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.
次要结局
- 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)