- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02622776
Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE)
March 5, 2019 updated by: Anna Tinker
Advanced Methods for Cancer Detection by Vaginal Screening (ADVISE): A Pilot Study of Using Vaginal Cell Sampling for Ovarian or Endometrial Cancer Detection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V6M 1E6
- BC Cancer Agency
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Vaginal DNA Collection
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.
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Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 months
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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)..
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24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Tinker, MD, British Columbia Cancer Agency
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
December 1, 2015
First Submitted That Met QC Criteria
December 2, 2015
First Posted (Estimate)
December 7, 2015
Study Record Updates
Last Update Posted (Actual)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 5, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESR-15-10795
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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