Research on biomarkers in ovarian cancer patients
Biomarker Discovery Project in High Grade Serous Ovarian Cancer
This study is collecting blood and tissue samples from women with advanced ovarian cancer to see if certain markers can help doctors understand the disease better and make more informed treatment choices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 7 sites (Barrie, Ontario and 6 other locations) |
| Trial ID | NCT03419689 on ClinicalTrials.gov |
What this trial studies
This study collects biological samples, including blood, tumor tissue, and other fluids, from patients diagnosed with advanced gynecological cancers, specifically high grade serous ovarian, tubal, or primary peritoneal cancer. The samples will be analyzed for biomarkers that may help in understanding the disease and guiding treatment decisions. Participants will receive the results of the testing, which can be shared with their treating physicians to inform their care. The study aims to enhance the understanding of ovarian cancer and improve patient outcomes through biomarker research.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of stage III or IV high grade serous ovarian, tubal, or primary peritoneal cancer.
Not a fit: Patients with early-stage (I and II) high grade serous cancers or those with other tumor histologies will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more personalized and effective treatment options for patients with advanced ovarian cancer.
How similar studies have performed: While this approach to biomarker research is common, the specific focus on advanced gynecological cancers may provide novel insights that have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer. * Must be 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. * Have a life expectancy greater than or equal to 6 months. * Able to provide adequate informed consent. * Willing to undergo blood or fluid collection and tumour biopsy * Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study. * Archival tissue must be available for patients that are enrolled at the time of progression. Exclusion Criteria: * Must not have early stage (I and II) high grade serous, tubal or primary peritoneal cancer. * Must not have other tumour histology other than high grade serous. * Must not have contraindication to tumour biopsy and/or blood sampling.
Where this trial is running
Barrie, Ontario and 6 other locations
- Royal Victoria Regional Health Centre — Barrie, Ontario, Canada (Recruiting)
- Juravinski Cancer Centre — Hamilton, Ontario, Canada (Active_not_recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amit Oza, M.D. — Princess Margaret Cancer Centre
- Study coordinator: Amit Oza, M.D.
- Email: amit.oza@uhn.ca
- Phone: 416-946-2818
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.