Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)
研究概览
简要总结
This pilot study is the first step in the development of an new assay that may be further tested as a screening method for ovarian and endometrial cancers.
详细描述
Most high grade ovarian cancers originate in the fallopian tubes. Since the lining of the fallopian tube opens into the uterine cavity cancer cells from ovarian/fallopian tube cancers can travel through the uterus to the cervix and vagina. Likewise, endometrial cancer cells shed through the cervix into the vagina. It may be possible to develop a screening test for ovarian and endometrial cancers by collecting vaginal cells.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ovarian Cancer and Endometrial Cancer cases:
- •Women age 19 or older.
- •Histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial cancer, not yet treated by surgery or chemotherapy.
- •Give consent to access primary tumour tissue following surgery or biopsy.
- •Healthy participants:
- •Healthy women between the ages of 19 and 60.
排除标准
- •Ovarian Cancer and Endometrial Cancer cases:
- •Women with self-reported, known pregnancy.
- •Healthy participants:
- •Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded.
- •Women who report irregular bleeding (spotting between menstrual cycles, or post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are ineligible.
- •Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be eligible to participate as healthy volunteers for this study.
- •Women with self-reported, known pregnancy.
结局指标
主要结局
Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)
时间窗: 24 months
An 8 question questionnaire will be used to measure the acceptability of the DNA collection methods being used in this study (self-swab and tampon based collection)..
Assay sensitivity and specificity as assessed by the mutation detection rate in tumour and vaginal DNA
时间窗: 24 months
Vaginal DNA and tumour DNA will be compared to determine the mutation detection rate of the assay. Vaginal DNA from normal samples will determine if a background rate of somatic mutations is present in healthy women.
次要结局
未报告次要终点
研究者
Anna Tinker
Medical Oncologist
British Columbia Cancer Agency