Status:
RECRUITING
Study of Biomarkers in Gynecological Cancers
Lead Sponsor:
University Health Network, Toronto
Conditions:
Gynecologic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome. Research has shown that...
Eligibility Criteria
Inclusion
- Pre-Screening Eligibility:
- Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation
- Patient must be ≥16 years of age at the time of consent.
- Ability to understand and provide written informed consent.
- ECOG Performance Status ≤ 2.
- Patient must consent to provide tissue sample from surgery and blood samples
- Life expectancy ≥3 months.
Exclusion
- Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)
- Eligibility for Patients with Gynecological Diagnosis
- Inclusion Criteria:
- Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).
- Patient must be ≥16 years of age at the time of consent.
- Ability to understand and provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.
- Life expectancy ≥3 months.
- No limits of previous lines of treatment.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03420118
Start Date
December 21 2017
End Date
December 21 2027
Last Update
December 5 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5