Gynecologic Cancer
Conditions
Brief summary
This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.
Interventions
PROCEDURETumour tissue collection
Tumour tissue will be taken from samples already removed from surgery or biopsy or by new tumour biopsies: * At the time of diagnosis or progression * Any surgical procedures for management of tumour related medical conditions * At each subsequent relapse or disease progression
PROCEDUREBlood sample collection
Blood samples will be taken: * At the time of first diagnosis * About 1 week after starting any treatment * At each radiological response assessment * At each subsequent relapse or disease progression
PROCEDUREAscites Collection
Ascites will be collected if paracentesis is required during any of the following time points: * At the time of diagnosis or progression * Any surgical procedures for management of tumour related medical conditions * At each subsequent relapse or disease progression
PROCEDUREFluid Collection
Additional fluid will be collected at any time a procedure for clinical management that involves the drainage of fluid (i.e. thoracentesis, or drainage of cystic lesion) is required.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genomic and immune signatures in terms of progression free survival | 10 years | Short term (1-2 years) versus long term (5-10 years) survival |
| Genomic and immune signatures in terms of overall survival | 10 years | Short term (1-2 years) versus long term (5-10 years) survival |
| Genomic and immune signatures in terms of response to treatments | 10 years | — |
| Genomic and immune signatures in terms of resistance to treatments | 10 years | — |
Countries
Canada
Contacts
Primary ContactAmit Oza, M.D.
Outcome results
None listed