Advanced Methods for Cancer Detection by Vaginal Screening

Ovarian Cancer Clinical Trial

— ADVISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622776
• Other study ID #: ESR-15-10795
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer

Intervention

Other:
• Vaginal DNA Collection
Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire

Locations

Country	Name	City	State
Canada	BC Cancer Agency	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Anna Tinker

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	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)..	24 months