DOvEEgene Fleur: New Uterine Sampling Tool
DOvEEgene Fleur: New Uterine Sampling Tool
This study is related to a previous study from the same group which started in 2014
 (NTC02288676, McGill REB A08-M79-13B, MUHC REB 2020-5945) to develop a clinically
 implementable screening test -DovEEgene: developing and validating a novel molecular test for
 the early diagnosis of cancer of the endometrium, tubes and ovaries. This study is designed
 to identify endometrial, tubal and ovarian cancer very early based on identifying
 cancer-specific mutations (cancer DNA) in a pap sample taken from inside the uterus. The
 results are particularly encouraging given that control group is challenging with high
 background mutational burden from benign tumours, endometriosis, germ-line mutations etc.

 To date, all the intrauterine samples were obtained using the commercially available TAO
 brush™ which is designed to take an endometrial sample. However, when patient tolerability
 was assessed using a numerical pain scale (NPS) ranging from 0 (no pain) to 10 (severe pain),
 patients rated the sampling using the TAO brush™ at 3.5 versus 0 for a cervical pap sample.
 These results were not surprising as the TAO brush™ was designed for dislodging strips of
 endometrial tissue to use for histopathologic examination. With respect to the investigators
 objective, which is to collect cancer cells that have exfoliated to the uterus, a sampler
 that collects these exfoliated cells with as little disturbance as possible to the underlying
 endometrium is preferred. In this sub-study, the investigators aim to evaluate a new
 endometrial sampling tool, the DOvEEgene Fleur, which is believe to be superior to the
 current TAO brush™ in terms of cancer detection, ease of use and patient tolerability. The
 sampler has been designed using materials/components found in the TAO brush™ and other
 approved medical devices.
Inclusion Criteria:

 -  Be at least 18 years of age.

 -  Have capacity to understand the study.

 -  Be able to provide informed consent.

 -  If the patient has a recently treated cervical abnormality, she must have had a Pap
 smear with normal results at least 4 months following treatment by loop
 electrosurgical excision procedure (LEEP) or cone biopsy.

 -  Have suspected or confirmed cancer of the upper genital tract and be undergoing
 surgery for said tumor removal.

 Exclusion Criteria:

 -  Prior hysterectomy.

 -  Be pregnant or possibly pregnant.

 -  Be nursing, as the device contains phthalates (plasticizers) that "have not been fully
 characterized and there may be concern for reproductive and developmental effects".

 -  Have an infected or inflamed cervix.

 -  Have a confirmed or suspected pelvic infection.

 -  Have a confirmed or suspected vaginal infection.

 -  Have had recent history of uterine perforation.

 -  Patients with recently treated cervical abnormalities must have a Pap smear with
 normal results at least 4 months following treatment by loop electrosurgical excision
 procedure (LEEP) or cone biopsy in order to be eligible.