Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility and Acceptability of Self-collected Vaginal DNA to Assess for the Presence of Mutations Related to EC or EC Precursors
研究概览
简要总结
The goal of this study is to find out if self-collected vaginal swabs can be used to detect early signs of uterine cancer or related conditions in people with Lynch syndrome (LS) who still have their uterus. The study also tests if people with LS are willing and able to collect these samples themselves and whether they find the process acceptable.
The main questions this study asks are:
- Will people with LS take part in self-collection of vaginal samples, and do they find it acceptable?
- Can vaginal DNA mutations predict cancer risk or match results from other genetic or biopsy testing?
- Can a cancer risk model used in the general population also help identify risk in people with LS?
Participants will:
- Answer a health questionnaire about lifestyle and symptoms
- Collect their own vaginal swabs and measure their vaginal pH at home using a self-collection kit
- Complete short surveys around the time of self-collection and at the end of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Lynch syndrome (confirmed by genetic testing).
- •Have an intact uterus.
- •Age 30 years or older.
排除标准
- •History of endometrial cancer or endometrial hyperplasia.
- •History of pelvic radiation or endometrial ablation.
- •Pregnant at the time of study enrolment or during the study.
研究组 & 干预措施
Vaginal self-collection
Participants will receive up to three at-home collection kits with a vaginal swab for DNA collection, a vaginal swab for microbiome sampling, a vaginal pH testing kit, and instructions on how to perform the sample collection. Vaginal DNA will be collected using Zymo DNA/RNA Shield, vaginal microbiome DNA will be collected using Genotek OMNIgene, and vaginal pH will be collected using GYNEX pHem-Alert.
Participants with abnormal findings will be referred to a gynecologist or gynecologic oncologist for appropriate clinical assessment. Those with negative pathology will remain in the study. The self-collection will be repeated up to two more times, at eight-to-nine-month intervals, up to three successful self-collections.
干预措施: Vaginal DNA swab, microbiome swab and pH test (Combination Product)
结局指标
主要结局
Feasibility and Acceptability of Self-collected Vaginal DNA to Assess for the Presence of Mutations Related to EC or EC Precursors
时间窗: Through study completion, anticipated 1-2 years
Feasibility will be measured by enrollment and adherence rates. Enrollment is defined as interested individuals completing the first round of self-collection. Adherence is defined as compliance with returning vaginal DNA samples, completing the health questionnaire, and submitting the exit survey. Acceptability will be measured through responses to a questionnaire post-self-collection and an exit survey, evaluating ease and overall experience with the self-collection process.
次要结局
未报告次要终点
研究者
Aline Talhouk
Principal Investigator
University of British Columbia