Study Looking at Biomarkers in Ovarian Cancer

University Health Network, Toronto

Status

Enrolling

Conditions

Gynecologic Cancer

Treatments

Procedure: Blood sample collection

Procedure: Fluid Collection

Procedure: Ascites Collection

Procedure: Tumour tissue collection

Study type

Interventional

Funder types

Other

Identifiers

NCT03419689

BioDIVA (17-5467)

Details and patient eligibility

About

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.

Enrollment

510 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.