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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal DNA Collection | Other | Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Ovarian Cancer and Endometrial Cancer cases:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Tinker, MD | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency | Vancouver | British Columbia | V6M 1E6 | Canada |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |