Screening for Cervical Intraepithelial Neoplasia Using Self-collected Menstrual Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen
研究概览
简要总结
The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.
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
- •There will be two study groups: 1) menstruating women over the age of 18 who have previous history of HR-HPV in the last 18 months and 2) menstruating women over the age of 18 who do not have a previous history of HR-HPV.
排除标准
- •Women younger than 18 years old or are not menstruating regularly
结局指标
主要结局
Agreement Between Modified Menstrual Pad and Clinician-Collected Specimen
时间窗: 2-4-months after initial clinician collected samples were obtained and sent for HR-HPV DNA or HPV E6/E7 mRNA
The clinician collected a vaginal swab to detect HPV, then participants used a modified menstrual pad to self-collect a sample within 2 months of the clinician collected swab (may have happened at up to 4 mo.). Participants may have had prior history of dysplasia or HPV positivity, or were from general population receiving regular check-up. Agreement between the clinician-collected swabs and participant-collected menstrual samples was assessed in: * Participants who sent their sample to the lab within 2 months, and whose sample was analyzed for the presence of HPV * Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken (if clinically appropriate) showing moderate-to-severe dysplasia (cervical intraepithelial neoplasia \[CIN\] 2 or worse) * Participants enrolled at the time of a previously scheduled colposcopy, with a biopsy taken showing moderate-to-severe dysplasia, and participants whose laboratory results indicated presence of high-risk HPV.
Agreement Between Self-collected Vaginal Swabs vs Clinician-collected Cervical Specimens With High-risk HPV-Positive Results
时间窗: 2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA
次要结局
- Number of Participants Who Opted Out of Self-swab Due to Discomfort With the Procedure(2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA)
- Number of Participants Who Preferred the Modified Menstrual Pad to Clinician-collected Cervical Specimens(2-4-months after initial positive screen for HR-HPV DNA or HPV E6/E7 mRNA)
研究者
Paul D Blumenthal
Professor
Stanford University