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Advanced Methods for Cancer Detection by Vaginal Screening

Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection

NCT02622776•Anna Tinker

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

19 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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

Key Dates

Start Date

February 1, 2016

Primary Completion Date

August 1, 2018

Completion Date

December 1, 2018

Last Updated

March 6, 2019

Enrollment

122

ACTUAL participants

Conditions

Ovarian CancerEndometrial Cancer

Interventions

Vaginal DNA Collection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Advanced Methods for Cancer Detection by Vaginal Screening

Inclusion Criteria

Exclusion Criteria

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