Ovarian Tumor Biopsies to Study Response to Treatments
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- Procedure: Blood DrawProcedure: Tumor Tissue Biopsy
- Registration Number
- NCT02952521
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.
- Detailed Description
Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.
The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 5
- Age ≥18 years.
- Histological diagnosis of epithelial ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy of greater than 3 months
- Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
- Must be agreeable to paired biopsies
- Must have disease amenable to paired biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
- Any contraindication to biopsy
- Need for anticoagulation that cannot be interrupted
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Epithelial ovarian cancer Tumor Tissue Biopsy * Whole blood sample collection * Up to 3 fresh tumor tissue core biopsies * Tumor tissue sample taken from tumor tissue already removed from surgery (if surgery is planned) Epithelial ovarian cancer Blood Draw * Whole blood sample collection * Up to 3 fresh tumor tissue core biopsies * Tumor tissue sample taken from tumor tissue already removed from surgery (if surgery is planned)
- Primary Outcome Measures
Name Time Method Pearson correlation for changes between kinome and CA125 5 years Paired T-test for differences in kinome between responders and non-responders 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada