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DOvEEgene Fleur: New Uterine Sampling Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258449
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
GSE Biomedical
Information provided by (Responsible Party):
Dr. Lucy Gilbert, McGill University

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 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

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participating hospital runs multiple weekly routine gynecologic oncology clinics. The cases include women scheduled to undergo surgery for tumor removal, for either proven or suspected upper genital tract cancer.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Dr. Lucy Gilbert, MD,MSc,FRCOG (514) 934-1934 ext 34049 lucy.gilbert@mcgill.ca
Contact: Dr. Claudia Martins, PhD (514) 934-1934 ext 35249 claudia.martins@mcgill.ca

Sponsors and Collaborators
McGill University
McGill University Health Centre/Research Institute of the McGill University Health Centre
GSE Biomedical
Additional Information:
Publications:

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Responsible Party: Dr. Lucy Gilbert, Professor Department of Obstetrics & Gynecology and Department of Oncology, McGill University
ClinicalTrials.gov Identifier: NCT04258449    
Other Study ID Numbers: 2020-6016
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Lucy Gilbert, McGill University:
Ovarian Cancer
Endometrial Cancer
Genomics
DNA tagging
Somatic mutations
Endometrial sampling
Uterine sampling
Medical device
Uterine biofluid