Detecting endometrial and ovarian cancer early using a genomic test
Phase III Diagnostic Trial for Early Detection of Endometrial/Ovarian Cancer and Hereditary Predisposition of These Cancers
This study is testing a new genomic test to see if it can help find endometrial and ovarian cancers earlier in women who don't have any symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5600 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | McGill University Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT04891029 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the early detection of endometrial and ovarian cancers by utilizing a novel genomic assay called the DOvEEgene test. The research builds on previous findings that highlighted the limitations of current screening methods, such as transvaginal ultrasound and CA-125 tests, which often fail to identify cancers until they are at an advanced stage. By screening asymptomatic women, the study seeks to identify these cancers earlier in their development, potentially leading to better treatment outcomes. The study is being conducted at multiple locations in Montreal, Quebec, under the auspices of McGill University and its research partners.
Who should consider this trial
Good fit: Ideal candidates for this study are asymptomatic women who are capable of providing informed consent.
Not a fit: Patients who have had a prior hysterectomy, are pregnant, nursing, undergoing fertility treatment, or have a recent history of uterine perforation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and treatment of endometrial and ovarian cancers, improving survival rates.
How similar studies have performed: Previous studies have shown that early detection methods can improve outcomes, but this genomic approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Capacity to understand study and provide informed consent Exclusion Criteria: * Prior hysterectomy * Be pregnant * Be nursing * Be undergoing any fertility treatment * Have had recent history of uterine perforation
Where this trial is running
Montreal, Quebec and 1 other locations
- McGill University Health Centre, Royal Victoria Hospital — Montreal, Quebec, Canada (Recruiting)
- Queen Elizabeth Health Complex — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Lucy Gilbert, MD
- Email: gyne-oncologysec@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.