Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
研究概览
简要总结
The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age (no upper age limit)
- •AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
- •Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
- •Scheduled for definitive CRT as primary treatment of their oropharynx cancer
排除标准
- •Prior history of radiation therapy to the head and neck
- •Prior history of mucosal head and neck cancer.
- •Not willing or able to comply with study specific procedures
研究组 & 干预措施
Assessment of Oral HPV Infection
Oral HPV infection will be assessed 14 times, once prior to starting CRT, weekly during CRT, and then serially post-treatment: 4-8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months. Patients will provide samples of their saliva and exfoliated epithelial cells at these timepoints. Samples will be collected with supplies provided by and analyzed by OralDNA Labs.
干预措施: Assessment of Oral HPV Infection (Other)
结局指标
主要结局
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
时间窗: 2 years post-CRT of last enrolled patient
次要结局
- Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT(2 years post-CRT of last enrolled patient)
- Number of aneuploidy cells as measured by FISH (Florescent in-situ hybridization) and the mRNA copy number for HPV E6 and HPV E7 at each time-point(2 years post-CRT of last enrolled patient)
- Clinical outcomes of interest (local control, loco-regional control, distant metastasis-free survival, and overall survival (OS)) in patients with HPV-positive OPSCC undergoing CRT(2 years post-CRT of last enrolled patient)