Early diagnosis of ovarian and endometrial cancer using genomic testing
DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
This study is testing a new DNA test to see if it can help catch ovarian and endometrial cancers early by looking for specific changes in samples taken from the cervix and uterus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | McGill University Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT02288676 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a genomic test for the early diagnosis of ovarian and endometrial cancers by detecting somatic mutations in biofluid samples collected from the cervix and uterine cavity. Given the high mortality rates associated with late-stage diagnoses, the research focuses on utilizing advanced DNA-tagging technologies to identify cancer-associated mutations at an early stage. The goal is to create a highly sensitive and specific assay that can be automated for high-throughput testing, potentially transforming the current diagnostic approach for these cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are women with suspected or confirmed cancer of the upper genital tract who are scheduled for tumor removal surgery.
Not a fit: Patients with benign conditions who are not undergoing surgery for cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could significantly improve early detection rates of ovarian and endometrial cancers, leading to better patient outcomes and survival rates.
How similar studies have performed: Other studies utilizing genomic approaches for early cancer detection have shown promise, indicating that this method could be a viable option for diagnosing ovarian and endometrial cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Case Inclusion: * Subjects should have suspected or confirmed cancer of the upper genital tract. * Participant will undergo surgery for tumour removal. Control inclusion: • Subjects should be scheduled to have a hysterectomy, bilateral salpingectomy, with or without bilateral oophorectomy, for presumed benign disease.
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.