Study of Biomarkers in Gynecological Cancers

Molecular and Immunological Characterization of Gynecological Malignancies

In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome.

Research has shown that changes in some genes and/or proteins may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and how to target them to stop or reduce cancer growth.

A drug that may be able to block certain specific cancer cell changes is called "targeted therapy". Different people with the same type of cancer receiving the same drug could have different responses to it. For example, one person may experience a reduction of their tumor while another person's cancer may worsen. The reason for this is still not well understood and could lie in gene changes.

Understanding these changes may allow researchers to predict how treatments may work in guiding decisions around choice of drugs.

The purpose of the study is to learn more about gene changes or protein expression (levels) of tumors to better understand the behavior of gynecological diseases and, if possible, better address participants' cancer care now or in the future.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Procedure: Tumour tissue collection; Procedure: Blood draws

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit Oza, M.D.; Phone Number: 416-946-2818; Email: amit.oza@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Amit Oza, M.D.; Phone Number: 416-946-2818; Email: amit.oza@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Pre-Screening Eligibility:

Inclusion Criteria:

• Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation
• Patient must be ≥16 years of age at the time of consent.
• Ability to understand and provide written informed consent.
• ECOG Performance Status ≤ 2.
• Patient must consent to provide tissue sample from surgery and blood samples
• Life expectancy ≥3 months.

Exclusion Criteria:

• Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)

Eligibility for Patients with Gynecological Diagnosis

Inclusion Criteria:

• Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).
• Patient must be ≥16 years of age at the time of consent.
• Ability to understand and provide written informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.
• Life expectancy ≥3 months.
• No limits of previous lines of treatment.

Exclusion Criteria:

• Any contraindication to tumour biopsy or blood collection
• Patient with diagnosis of High grade serous Ovarian Cancer are excluded

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tumor tissue and blood samples collection

Procedure: Tumour tissue collection; Depending on the status of disease when participants join the study, a sample of tumour tissue may be collected from: A previous surgery for the disease,; A biopsy for diagnosing the disease,; Other surgical procedures done for clinical management or possible cancer related complications (e.g., bowel obstruction). In addition: Patients undergoing pre-screening prior to diagnosis will have tumour sample collected at the time of surgery.; At anytime participants require a biopsy as a part of their cancer care, a sample of that tumour tissue will be collected.; New biopsies will be done to collect fresh tumour tissue each time participants' disease worsens.; Procedure: Blood draws; Blood samples will be collected at the following different times points: All patient undergoing pre-screening for histological diagnosis will have blood samples collected.; Before starting a new line of treatment for the disease,; One week after starting a new line of treatment for the disease,; During treatment, at each radiological assessment (imaging scan) that will be done to check the status of the disease,; At the time the disease worsens or relapses (comes back); During observation/follow-up, at the time of any radiological assessments that will be done to check the status of the disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Genomic and immune signatures in terms of progression free survival	5 years
Genomic and immune signatures in terms of overall survival	5 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Amit Oza, M.D., Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Estimated): December 21, 2024
• Study Completion (Estimated): December 21, 2025

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VENUS; 17-5411 (Other Identifier: UHN REB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No