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DOvEEgene Fleur: New Uterine Sampling Tool

Recruitingn/aAges 18 Years - anyFemaleMcGill University
NCT04258449 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • DOvEEgene Fleur Sampling
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Where

1 site
Royal Victoria Hospital (Glen Site)
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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