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临床试验/NCT03644563
NCT03644563进行中(未招募)不适用

Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,500
试验地点
1
主要终点
Oncogenic oral HPV infection present or absent in oral rinse sample

研究概览

简要总结

This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.

详细描述

This study will provide one of the first estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on this natural history. Phase 1 of the study will screen approximately 1500 people for oncogenic oral HPV biomarkers. Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or HPV serum oncogene antibodies from Phase 1 (and those previously identified as having oncogenic oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV persistence.

Understanding persistent oncogenic oral HPV infection is the focus of this study. Understanding which factors drive oral HPV infection to become persistent or progress to malignancy is critical to determine who is at high risk for oropharyngeal cancer and may benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV infections are necessary for progression to HPV-OPC.

The study is led by Dr. Amber D'Souza and Dr Carole Fakhry (Johns Hopkins) and participants are being enrolled in Baltimore MD (Johns Hopkins) and in New York (Mt. Sinai).

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
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Oncogenic oral HPV infection present or absent in oral rinse sample

时间窗: Baseline to end of four year follow-up and data abstraction/linkage.

To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence

次要结局

  • HPV16 E6 antibodies present or absent in serum sample(Baseline to end of four year follow-up and data abstraction/linkage.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Men and Women Offering Understanding of Throat HPV | 临床试验