Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE)

Anna Tinker

Status: Completed

Conditions: Endometrial Cancer; Ovarian Cancer

Treatments: Other: Vaginal DNA Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02622776

ESR-15-10795

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

Vaginal DNA Collection

Other group

Description:

Patients with a diagnosis of ovarian cancer or endometrial cancer who have not yet had surgery, chemotherapy or radiation may be able eligible to participate. Patients unaffected by cancer may be able to participate.

Treatment:

Other: Vaginal DNA Collection