New tool for uterine sampling to detect gynecological cancers
DOvEEgene Fleur: New Uterine Sampling Tool
This study is testing a new tool to see if it can help find signs of gynecological cancers in women who are having surgery for tumors by looking for cancer DNA in samples taken from the uterus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | McGill University Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04258449 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a novel molecular test called DOvEEgene, which focuses on early diagnosis of endometrial, tubal, and ovarian cancers by identifying cancer-specific mutations in pap samples taken from the uterus. The study builds on previous research and seeks to improve patient tolerability during sampling by using a new uterine sampling tool. Participants will include women with suspected or confirmed gynecological diseases who are undergoing surgery for tumor removal. The study will assess the effectiveness of this new tool in detecting cancer DNA amidst a challenging background of benign conditions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with suspected or confirmed cancer of the upper genital tract who are scheduled for surgery.
Not a fit: Patients who have had a prior hysterectomy or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of gynecological cancers, improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using molecular tests for cancer detection, making this approach a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- Royal Victoria Hospital (Glen Site) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Dr. Lucy Gilbert, MD,MSc,FRCOG
- Email: lucy.gilbert@mcgill.ca
- Phone: (514) 934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.