NCT06434337招募中不适用
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
研究概览
简要总结
To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.
详细描述
Primary Objectives
1. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
Secondary Objectives
- To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
- To assess how different sample processing methods affect the performance of the Rice HPV test.
- To assess how different test readout methods affect the performance of the Rice HPV test.
Exploratory Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •People with a cervix 21 years of age or older.
- •Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment OR are anticipated to undergo a LEEP, ECC, or biopsy.
- •Willing and able to provide informed consent.
- •Able to perform protocol-required activities. Able to speak and read English or Spanish.
排除标准
- •Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy.
- •Participant or provider decision not to collect a sample for this study.
- •Participants that are pregnant.
结局指标
主要结局
Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
时间窗: Through study completion; an average of 1 year
To evaluate the performance of the 3 version of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
次要结局
未报告次要终点
研究者
研究点 (2)
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