Prospective Assessment of HPV Associated Anogenital Pathology in Female Patients and Female Partners of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (PAP-OP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC
研究概览
简要总结
This study evaluates how often women with throat (oropharyngeal) cancer or who have a partner with oropharyngeal cancer get anogenital infections with high risk, potentially cancer-causing types of human papilloma virus (HPV).
详细描述
PRIMARY OBJECTIVES:
I. Prospectively determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.
II. To determine the risk of requiring additional procedures or treatments secondary to these diagnoses.
III. To determine the sexual health and well-being among patients and partners with HPV(+)OPSCC.
IV. To develop standardized patient education and recommendations for referral and screening for this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •* Female patients with diagnosed HPV(+)OPSCC seen at the Mayo Clinic, Rochester
- •Female partners of Mayo Clinic patients with diagnosed HPV(+)OPSCC
- •Patient has given permission to give his/her blood/saliva sample for research testing
- •Ability to complete questionnaire(s) by themselves or with assistance
排除标准
- •* HPV(-) OPSCC
- •Unable to provide informed consent
- •Unwilling to attend screening visit at Mayo Clinic site, if indicated
- •Unwilling/unable to complete surveys electronically
研究组 & 干预措施
Observational
Participants complete surveys, watch an educational video on HPV vaccination and undergo collection of blood and saliva samples on study. Patients also undergo cervical screening per standard of care and may receive a referral to gynecology if not up to date on anogenital screening.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Incidence and prevalence of HPV(+) associated anogenital pathology in patients with newly diagnosed HPV(+)OPSCC
时间窗: Baseline (at enrollment)
Prevalence and incidence of human papilloma virus (HPV)-related anogenital disease in female patients with HPV-mediated oropharyngeal squamous cell carcinoma (HPV(+)OPSCC) will be compared to a population of patients with similar demographic and comorbidity status. Rates will be compared across groups using tests for proportional variables (Fisher's exact, Chi Square).
Incidence and prevalence of HPV(+) associated anogenital pathology in partners of patients with newly diagnosed HPV(+)OPSCC
时间窗: Baseline (at enrollment)
Prevalence and incidence of human papilloma virus (HPV)-related anogenital disease in female partners of HPV-mediated oropharyngeal squamous cell carcinoma (HPV(+)OPSCC) patients will be compared to a population of patients with similar demographic and comorbidity status. Rates will be compared across groups using tests for proportional variables (Fisher's exact, Chi Square).
次要结局
未报告次要终点