Study Looking at Biomarkers in Ovarian Cancer

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT03419689

Collaborator

(none)

510

Enrollment

Locations

Arm

101

Anticipated Duration (Months)

72.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer	Procedure: Tumour tissue collection Procedure: Blood sample collection Procedure: Ascites Collection Procedure: Fluid Collection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

510 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Actual Study Start Date :

Jan 8, 2018

Anticipated Primary Completion Date :

Jun 8, 2026

Anticipated Study Completion Date :

Jun 8, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sample Collection The following samples may be collected during the study: Tumour tissue samples Blood samples Ascites samples Other fluids requiring drainage	Procedure: 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 Procedure: 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 Procedure: 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 Procedure: 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.

Arm

Intervention/Treatment

Experimental: Sample Collection

The following samples may be collected during the study: Tumour tissue samples Blood samples Ascites samples Other fluids requiring drainage

Procedure: 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

Procedure: 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

Procedure: 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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Regional Health Centre	Barrie	Ontario	Canada	L4M 6M2
2	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
3	Kingston Health Sciences Centre	Kingston	Ontario	Canada	K7L 2V7
4	London Health Sciences Centre	London	Ontario	Canada
5	The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6
6	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
7	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 1Z5

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Amit Oza, M.D., Princess Margaret Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03419689

Other Study ID Numbers:

BioDIVA (17-5467)

First Posted:

Feb 5, 2018

Last Update Posted:

Dec 13, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 13, 2021