Trial details

Trial short name: BioDIVA

Official title: Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Principal Investigator: Dr. Helen MacKay

Cancer type: Gynecology
Cancer location: Gynecology
Disease stage: Early Cancer
Trial phase: Other
Intervention:

Registration #: NCT03419689

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial description:
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.

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.