Study Looking at Biomarkers in Ovarian Cancer

NCT ID: NCT03419689

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2028-06-08

Brief Summary

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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

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Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sample Collection

The following samples may be collected during the study:

* Tumour tissue samples
* Blood samples
* Ascites samples
* Other fluids requiring drainage

Group Type EXPERIMENTAL

Tumour tissue collection

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit Oza, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Site Status RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Amit Oza, M.D.

Role: CONTACT

416-946-2818

Facility Contacts

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Leah Jutzi, MD

Role: primary

705-728-9090

Josee-Lyne Ethier, M.D.

Role: primary

Stephen Welch, MD

Role: primary

519-685-8600 ext. 53346

Johanne Weberpals, M.D.

Role: primary

Helen MacKay, MD

Role: primary

416-480-5145

Amit Oza, M.D.

Role: primary

416-946-2818

Other Identifiers

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BioDIVA (17-5467)

Identifier Type: -

Identifier Source: org_study_id

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