NCT03419689

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2018Jun 2028

First Submitted

Initial submission to the registry

August 8, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2028

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

10.4 years

First QC Date

August 8, 2017

Last Update Submit

December 3, 2025

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (4)

  • Genomic and immune signatures in terms of progression free survival

    Short term (1-2 years) versus long term (5-10 years) survival

    10 years

  • Genomic and immune signatures in terms of overall survival

    Short term (1-2 years) versus long term (5-10 years) survival

    10 years

  • Genomic and immune signatures in terms of response to treatments

    10 years

  • Genomic and immune signatures in terms of resistance to treatments

    10 years

Study Arms (1)

Sample Collection

EXPERIMENTAL

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

Procedure: Tumour tissue collectionProcedure: Blood sample collectionProcedure: Ascites CollectionProcedure: Fluid Collection

Interventions

Tumour tissue collectionPROCEDURE

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

Sample Collection
Blood sample collectionPROCEDURE

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

Sample Collection
Ascites CollectionPROCEDURE

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

Sample Collection
Fluid CollectionPROCEDURE

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.

Sample Collection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

ACTIVE NOT RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

Study Officials

  • Amit Oza, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Oza, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2017

First Posted

February 5, 2018

Study Start

January 8, 2018

Primary Completion (Estimated)

June 8, 2028

Study Completion (Estimated)

June 8, 2028

Last Updated

December 4, 2025

Record last verified: 2025-12

Locations

CA(7)