Treffer: Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection
Title:
Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection
Authors:
Publisher Information:
Anna Tinker, 2020.
Publication Year:
2020
Original Identifier:
ESR-15-10795
Document Type:
Report
Report
Language:
English
Other URLs:
Health Condition(s) or Problem(s) studied:
Ovarian Cancer;Endometrial Cancer
Interventions:
Other: Vaginal DNA Collection
Key inclusion & exclusion criteria:
Inclusion Criteria: Ovarian Cancer and Endometrial Cancer cases: 1. Women age 19 or older. 2. 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. 3. Give consent to access primary tumour tissue following surgery or biopsy. Healthy participants: 1) Healthy women between the ages of 19 and 60. Exclusion Criteria: Ovarian Cancer and Endometrial Cancer cases: 1. Women with self-reported, known pregnancy. Healthy participants: 2. Women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded. 3. 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. 4. Women with known Lynch Syndrome and/or BRCA1 or BRCA2 germline mutations will not be eligible to participate as healthy volunteers for this study. 5. Women with self-reported, known pregnancy.
Primary Outcomes:
Assay sensitivity and specificity as assessed by the mutation detection rate in tumour and vaginal DNA;Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)
Recruitment Status:
Completed
Study Design:
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
Study Type:
Interventional
Target Sample Size:
122
Accession Number:
edsict.NCT02622776
Database:
International Clinical Trials Registry Platform ICTRP