Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Looking at Biomarkers in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03419689
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Procedure: Tumour tissue collection Procedure: Blood sample collection Procedure: Ascites Collection Procedure: Fluid Collection Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
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 : January 8, 2018
Estimated Primary Completion Date : June 8, 2026
Estimated Study Completion Date : June 8, 2026


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. Genomic and immune signatures in terms of response to treatments [ Time Frame: 10 years ]
  4. Genomic and immune signatures in terms of resistance to treatments [ Time Frame: 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419689


Contacts
Layout table for location contacts
Contact: Amit Oza, M.D. 416-946-2818 amit.oza@uhn.ca

Locations
Layout table for location information
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Lorraine Elit, M.D.       elitlor@hhsc.ca   
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Josee-Lyne Ethier, M.D.       josee-lyne.ethier@kingstonhsc.ca   
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Johanne Weberpals, M.D.       jweberpals@toh.ca   
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Amit Oza, M.D.    416-946-2818    amit.oza@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre

Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03419689     History of Changes
Other Study ID Numbers: 17-5467
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No