DOvEEgene Fleur: New Uterine Sampling Tool

Study Overview
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Brief Summary
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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.

Official Title
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DOvEEgene Fleur: New Uterine Sampling Tool

Conditions
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Women With Suspected or Confirmed Gynecological Disease

Intervention / Treatment
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* Device: DOvEEgene Fleur Sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal. | Device: DOvEEgene Fleur Sampling<br>* Patients will undergo uterine sampling with DOvEEgene Fleur endometrial sampling device prior to surgical intervention, in addition to standard of care treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient related outcomes including pain and acceptability | Evaluate pain tolerability and acceptability during and after endometrial sample collection. This will be assessed using pain scores reported by participants on numeric pain scale (NPS) ranging from 0 to 10. Final pain scores with the DOvEEgene Fleur will be compared to historical pain scores collected with the TAO brush (Cook Medical). | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of performing sample collection by clinicians | Ease of use of the DOvEEgene Fleur will be evaluated through a physician feedback form. | up to 1 year | 
| Quality/quantity of sample collection | Molecular assessment to verify DOvEEgene Fleur is capable of detecting cancer cells from the uterus. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Endometrial Cancer, Genomics, DNA tagging, Somatic mutations, Endometrial sampling, Uterine sampling, Medical device, Uterine biofluid