Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project.
Lucy Gilbert, Olga Basso, John Sampalis...
https://pubmed.ncbi.nlm.nih.gov/22257524Actively Recruiting
Age: 18Years +
FEMALE
ID02288676
DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Led by McGill University · Updated on 2025-06-18
1200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
McGill University
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new test to detect ovarian and endometrial cancers early by identifying specific genetic mutations. These cancers are among the most common and deadly for women in high-income countries, mainly due to late-stage diagnosis. The study focuses on peri- and post-menopausal women and aims to improve early detection by analyzing mutations in samples from a uterine pap test and saliva, alongside advanced machine learning techniques. The test uses a panel of genes linked to ovarian and endometrial cancers and includes low-pass whole genome sequencing combined with a machine-learning classifier to distinguish cancer from benign gynecologic conditions. Participants are divided into two groups: those with suspected or confirmed upper genital tract cancer scheduled for tumor removal surgery, and those undergoing hysterectomy or related surgery for presumed benign conditions. The study collects samples and evaluates mutations over three years. Participants will provide uterine pap test and saliva samples for genetic analysis. Researchers will assess the presence of cancer-related mutations, patient experiences including pain and acceptability, and any risks associated with the test during the three-year period. The study is observational, gathering data and samples without altering treatment, with the goal of validating this genomic approach for early cancer diagnosis.
CONDITIONS
Brief Title
DOvEEgene/WISE Genomics: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female participants
- Age 18 years or older
- Suspected or confirmed cancer of the upper genital tract (uterine, tubal, or ovarian) for the case group
- Scheduled for surgery to remove tumor for the case group
- Scheduled for hysterectomy, bilateral salpingectomy, with or without bilateral oophorectomy, for presumed benign disease for the control group
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 3 years
Participants undergo testing to detect cancer-related mutations using genomic technologies.
Visits scheduled according to clinical care and testing needs
Surgery and Immediate Post-operative Care
Duration - Varies per participant
Participants scheduled for surgery to remove tumors or benign gynecologic tissue undergo surgical procedures and immediate recovery care.
1 to 2 visits depending on surgical scheduling and care
Long-term Monitoring
Duration - Up to 3 years
Participants are followed for up to 3 years to assess patient-related outcomes, risks, and detection of cancer-related mutations.
Periodic visits over 3 years depending on participant status
Trial Site Locations
Total: 1 location
1
Royal Victoria Hospital (Glen Site)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
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Research Team
D
Dr. Lucy Gilbert, MD,MSc,FRCOG
D
Dr. Claudia Martins, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Evaluation of DNA from the Papanicolaou test to detect ovarian and endometrial cancers.
Isaac Kinde, Chetan Bettegowda, Yuxuan Wang...
https://pubmed.ncbi.nlm.nih.gov/23303603The empress of subterfuge: cancer of the fallopian tube presenting with malapropism.
Lucy Gilbert, Timothée Revil, Charles Meunier...
https://pubmed.ncbi.nlm.nih.gov/28872014Evaluation of liquid from the Papanicolaou test and other liquid biopsies for the detection of endometrial and ovarian cancers.
Yuxuan Wang, Lu Li, Christopher Douville...
https://pubmed.ncbi.nlm.nih.gov/29563323