Advanced Methods for Cancer Detection by Vaginal Screening

NCT02622776 | Completed

• 1 other identifier: ESR-15-10795
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Vaginal DNA Collection

OTHER

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.

Other: Vaginal DNA Collection

Interventions

Vaginal DNA Collection OTHER

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

Vaginal DNA Collection

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Tinker: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V6M 1E6, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• Anna Tinker, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 7, 2015
• Study Start: February 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

CA (1)