RecruitingNot ApplicableNCT03419689

Study Looking at Biomarkers in Ovarian Cancer

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Sponsor

University Health Network, Toronto

Enrollment

510 participants

Start Date

Jan 8, 2018

Study Type

INTERVENTIONAL

Conditions

Gynecologic Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria3

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.

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.