DOvEEgene Fleur: New Uterine Sampling Tool
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|ClinicalTrials.gov Identifier: NCT04258449|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : September 1, 2020
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.
|Condition or disease||Intervention/treatment|
|Women With Suspected or Confirmed Gynecological Disease||Device: DOvEEgene Fleur Sampling|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||DOvEEgene Fleur: New Uterine Sampling Tool|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
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
Patients will undergo uterine sampling with DOvEEgene Fleur endometrial sampling device prior to surgical intervention, in addition to standard of care treatment.
- Patient related outcomes including pain and acceptability [ Time Frame: up to 1 year ]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).
- Feasibility of performing sample collection by clinicians [ Time Frame: up to 1 year ]Ease of use of the DOvEEgene Fleur will be evaluated through a physician feedback form.
- Quality/quantity of sample collection [ Time Frame: up to 1 year ]Molecular assessment to verify DOvEEgene Fleur is capable of detecting cancer cells from the uterus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258449
|Contact: Dr. Lucy Gilbert, MD,MSc,FRCOG||(514) 934-1934 ext firstname.lastname@example.org|
|Contact: Dr. Claudia Martins, PhD||(514) 934-1934 ext email@example.com|