Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04258449
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2020-02-04
Brief Title:
DOvEEgene Fleur New Uterine Sampling Tool
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
DOvEEgene Fleur New Uterine Sampling Tool
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 35 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 materialscomponents found in the TAO brush and other approved medical devices
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 35 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 materialscomponents found in the TAO brush and other approved medical devices
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None