Back to resultsAdvanced Methods for Cancer Detection by Vaginal Screening (ADVISE)
Primary Purpose
Ovarian Cancer, Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vaginal DNA Collection
Sponsored by
About this trial
This is an interventional screening trial for Ovarian Cancer
Eligibility Criteria
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:
1) 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.
Sites / Locations
- BC Cancer Agency
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vaginal DNA Collection
Arm 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.
Outcomes
Primary Outcome Measures
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.
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)..
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02622776
Brief Title
Advanced Methods for Cancer Detection by Vaginal Screening
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Tinker
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Endometrial Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaginal DNA Collection
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Vaginal DNA Collection
Intervention Description
Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire
Primary Outcome Measure Information:
Title
Assay sensitivity and specificity as assessed by the mutation detection rate in tumour and vaginal DNA
Description
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.
Time Frame
24 months
Title
Patient Acceptance of the methods of DNA collection (Vaginal self-swab and tampon collection)
Description
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)..
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
1) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Tinker, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6M 1E6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Advanced Methods for Cancer Detection by Vaginal Screening
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