Study Looking at Biomarkers in Ovarian Cancer

Gynecologic Cancer Clinical Trial

Official title:

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03419689
• Other study ID #: BioDIVA (17-5467)
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: June 8, 2026

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: Amit Oza, M.D.
• Phone: 416-946-2818
• Email: amit.oza[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: June 8, 2026
• Est. primary completion date: June 8, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic and immune signatures in terms of progression free survival	Short term (1-2 years) versus long term (5-10 years) survival	10 years
Primary	Genomic and immune signatures in terms of overall survival	Short term (1-2 years) versus long term (5-10 years) survival	10 years
Primary	Genomic and immune signatures in terms of response to treatments		10 years
Primary	Genomic and immune signatures in terms of resistance to treatments		10 years