Advanced Methods for Cancer Detection by Vaginal Screening

Anna Tinker122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

122

Conditions

Ovarian Cancer Endometrial Cancer

Interventions

Vaginal DNA CollectionOTHER

Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

BC Cancer Agency

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Assay sensitivity and specificity as assessed by the mutation detection rate in tumour and vaginal DNA

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.

Time frame: 24 months

Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)

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)..

Time frame: 24 months

Data from ClinicalTrials.gov

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