Study Looking at Biomarkers in Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer
• Interventions: Procedure: Tumour tissue collection; Procedure: Blood sample collection; Procedure: Ascites Collection; Procedure: Fluid Collection

• Registration Number: NCT03419689
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study Start: 2018-01-08
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01
• Primary Completion: 2026-06-08
• Study Completion: 2026-06-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 510

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sample Collection	Blood sample collection	The following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage
Sample Collection	Tumour tissue collection	The following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage
Sample Collection	Ascites Collection	The following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage
Sample Collection	Fluid Collection	The following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage

Primary Outcome Measures

Name	Time	Method
Genomic and immune signatures in terms of response to treatments	10 years
Genomic and immune signatures in terms of resistance to treatments	10 years
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

Trial Locations

Locations (7)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Regional Health Centre; 🇨🇦 Barrie, Ontario, Canada

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada