Study Looking at Biomarkers in Ovarian Cancer

NCT03419689 · tracked via the Priya Life Science Canada tracker

Sponsor

University Health Network, Toronto

Phase

Not applicable

Started

2018-01-08

Last updated

2025-12-04

Condition(s) studied

Gynecologic Cancer

Investigational drug(s) / intervention(s)

Tumour tissue collectionBlood sample collectionAscites CollectionFluid Collection

Tumour 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

Blood 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

Ascites 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

Fluid 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.

Study 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

FEMALE

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

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

Trial sites (7)

Facility	City	Region	Status
Royal Victoria Regional Health Centre	Barrie	Ontario	Recruiting
Juravinski Cancer Centre	Hamilton	Ontario	Active Not Recruiting
Kingston Health Sciences Centre	Kingston	Ontario	Recruiting
London Health Sciences Centre	London	Ontario	Recruiting
The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Recruiting
Sunnybrook Health Sciences Centre	Toronto	Ontario	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03419689 on ClinicalTrials.gov ↗ ← All trials in Canada