An interventional study of Vaginal DNA Collection in Ovarian Cancer and Endometrial Cancer, sponsored by Anna Tinker. Completed at 1 site in Canada. Open to female participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by Anna Tinker · Not applicable, Interventional, and Screening
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 122 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →This is the only study on the registry with Anna Tinker as lead sponsor.
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Ovarian Cancer and Endometrial Cancer cases:
Healthy participants:
Exclusion Criteria:
Ovarian Cancer and Endometrial Cancer cases:
Women with self-reported, known pregnancy.
Healthy participants:
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
Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire
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.
Time frame: 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)..
Time frame: 24 months
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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