DOvEEgene Fleur: New Uterine Sampling Tool

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Royal Victoria Hospital (Glen Site)
RECRUITING
Montreal
Contact Information
Primary
Dr. Lucy Gilbert, MD,MSc,FRCOG
lucy.gilbert@mcgill.ca
(514) 934-1934
Backup
Dr. Claudia Martins, PhD
claudia.martins@mcgill.ca
(514) 934-1934
Time Frame
Start Date: 2020-12-11
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 40
Treatments
Case
Participants must have suspected or confirmed upper genital tract cancer (uterine, tubal and ovarian) and must be scheduled to undergo surgery for tumor removal.
Sponsors
Collaborators: GSE Biomedical, McGill University Health Centre/Research Institute of the McGill University Health Centre
Leads: McGill University

This content was sourced from clinicaltrials.gov