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OpenTrials
Completed

NCT Number: NCT02622776

Advanced Methods for Cancer Detection by Vaginal Screening

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Vaginal DNA Collection

Other

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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)..

Sponsors and collaborators

Lead sponsor

Anna Tinker

Other

Registry information

Official study title

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

Acronym: ADVISE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2015
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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