Recruiting

Biomarkers

Sponsor:

University Health Network, Toronto

Code:

NCT03419689

Conditions

Gynecologic Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumour tissue collection

Blood sample collection

Ascites Collection

Fluid Collection

Study Details

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.

Conditions

Gynecologic Cancer

Study ID

NCT03419689

Start date

Jan 8, 2018

Status verified date

Dec, 2025

Completion date

Jun 8, 2028

Anticipated

Primary completion date

Jun 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

510 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Sample Collection

The following samples may be collected during the study:

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

Interventions

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

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

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

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 measure

  • Genomic and immune signatures in terms of progression free survival [ Time Frame: 10 years ]
  • Genomic and immune signatures in terms of overall survival [ Time Frame: 10 years ]
  • Genomic and immune signatures in terms of response to treatments [ Time Frame: 10 years ]
  • Genomic and immune signatures in terms of resistance to treatments [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Amit Oza, M.D.

416-946-2818amit.oza@uhn.ca

Locations

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Leah Jutzi, MD

705-728-9090jutzil@rvh.on.ca

Principal Investigator:

Leah Jutzi, MD

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Josee-Lyne Ethier, M.D.

josee-lyne.ethier@kingstonhsc.ca

London Health Sciences Centre

Recruiting

London, Ontario, Canada

Contacts

Stephen Welch, MD

519-685-8600stephen.welch@lhsc.on.ca

Principal Investigator:

Stephen Welch, MD

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Johanne Weberpals, M.D.

jweberpals@toh.ca

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Helen MacKay, MD

416-480-5145helen.mackay@sunnybrook.ca

Principal Investigator:

Helen MacKay, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

Contacts

Amit Oza, M.D.

416-946-2818amit.oza@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-04.