Study Looking at Biomarkers in Ovarian Cancer

July 27, 2023 updated by: University Health Network, Toronto

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Contact:
        • Principal Investigator:
          • Leah Jutzi, MD
      • Hamilton, Ontario, Canada, L8V 5C2
        • Active, not recruiting
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre
        • Principal Investigator:
          • Stephen Welch, MD
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital Cancer Centre
        • Contact:
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • SunnyBrook Health Sciences Centre
        • Principal Investigator:
          • Helen MacKay, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic and immune signatures in terms of progression free survival
Time Frame: 10 years
Short term (1-2 years) versus long term (5-10 years) survival
10 years
Genomic and immune signatures in terms of overall survival
Time Frame: 10 years
Short term (1-2 years) versus long term (5-10 years) survival
10 years
Genomic and immune signatures in terms of response to treatments
Time Frame: 10 years
10 years
Genomic and immune signatures in terms of resistance to treatments
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Estimated)

June 8, 2026

Study Completion (Estimated)

June 8, 2026

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BioDIVA (17-5467)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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