NCT01984359已完成不适用
A Pilot, Single-Center Study Of Quantitative HPV Serum Or Plasma DNA As A Prognostic Marker In P16+/HPV+ Squamous Carcinomas Of The Oropharynx And Unknown Primary Head And Neck Cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of subjects with Adverse Events
研究概览
简要总结
To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.
- •Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.
- •No or minimal smoking history (</= 10 pack-year, no smoking in the past 12 months last 10 years based on documented history and/or subject report)
- •Age 18 years or older
- •Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf.
- •Enrollment on any other study, regardless of therapy is allowed.
- •Enrollment on any other tumor or tissue banking study is allowed.
- •Patients who have had blood drawn as part of another study, including the IRB-approved ENT Tumor Bank Study, may be included in this study even if the patient has already had surgery.
排除标准
- •Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease.
- •Previous surgery for head and neck cancer unrelated to current disease.
- •Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed)
- •Patients who have started induction chemotherapy prior to consideration for study eligibility.
- •Another active cancer except nonmelanomatous skin cancer.
- •History of cervical penile or anal cancer.
- •Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania.
- •History of smoking in the past last 12 months 10 years
- •History of 10 pack-years of cigarette smoking based on documented history and/or subject report
- •Presence of sidespread leukoplakia or erythroplakia.
结局指标
主要结局
Number of subjects with Adverse Events
时间窗: 4 years
次要结局
未报告次要终点
研究者
研究点 (2)
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