Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: Dry Run of the ScreenUrSelf Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- HPV DNA using the Riatol qPCR HPV genotyping assay
研究概览
简要总结
The proposed study is the Dry Run preceding the ScreenUrSelf trial.
详细描述
The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practice within the organized cervical cancer screening program in Flanders).
The Dry Run which is the subject of this clinical trial will test the study materials and data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf trial. The primary outcome of the Dry Run is to check if the flow for data- and sample collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed necessary before start of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible for cervical cancer screening within the organized Population-based Screening Program in Flanders:
- •Residing in Flanders, Belgium
- •No history of total hysterectomy
- •No (former) diagnosis of cervical or uterine cancer
- •30 - 64 years old (birth year 1959 - 1992)
排除标准
- •Being pregnant or 6 weeks postpartum (self-reported after receiving the study letter/package)
- •Participation during menstruation or within the 3 following days is a contraindication
- •Not able to understand the study materials and participation form (informed consent form)
研究组 & 干预措施
Opt-out first-void urine
Women will receive a first-void urine self-sampling study package at home.
The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
干预措施: Colli-Pee Small Volumes (Device)
Opt-in first-void urine
Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.
The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
干预措施: Colli-Pee Small Volumes (Device)
Opt-out vaginal self-sample
Women will receive a vaginal self-sampling study package at home.
The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
干预措施: Evalyn Brush (Device)
Opt-in vaginal self-sample
Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.
The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
干预措施: Evalyn Brush (Device)
结局指标
主要结局
HPV DNA using the Riatol qPCR HPV genotyping assay
时间窗: Through study completion, an average of 1 year
HPV DNA concentration \[copies/µl DNA\] in self-samples from all study participants.
次要结局
- Human DNA (Beta-globin) using the Riatol qPCR HPV genotyping assay(Through study completion, an average of 1 year)
- Preferences(Through study completion, an average of 1 year)
研究者
Pierre Van Damme
Principal Investigator
Universiteit Antwerpen