Study of Biomarkers in Gynecological Cancers

• ClinicalTrials.gov Identifier: NCT03420118
• Recruitment Status: Recruiting
• First Posted: February 5, 2018
• Last Update Posted: February 5, 2024
• Sponsor: University Health Network, Toronto
• Information provided by (Responsible Party): University Health Network, Toronto

Tracking Information

• First Submitted Date: November 16, 2017
• First Posted Date: February 5, 2018
• Last Update Posted Date: February 5, 2024
• Actual Study Start Date: December 21, 2017
• Estimated Primary Completion Date: December 21, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2018)

• Genomic and immune signatures in terms of progression free survival [ Time Frame: 5 years ]
• Genomic and immune signatures in terms of overall survival [ Time Frame: 5 years ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Biomarkers in Gynecological Cancers
• Official Title: Molecular and Immunological Characterization of Gynecological Malignancies

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Gynecologic Cancer

Intervention

• 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

Study Arms

Experimental: Tumor tissue and blood samples collection

Interventions:

• Procedure: Tumour tissue collection
• Procedure: Blood draws

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 8, 2023): 500
• Original Estimated Enrollment (submitted: January 26, 2018): 250
• Estimated Study Completion Date: December 21, 2025
• Estimated Primary Completion Date: December 21, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Amit Oza, M.D.; 416-946-2818; amit.oza@uhn.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03420118
• Other Study ID Numbers: VENUS; 17-5411 ( Other Identifier: UHN REB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Health Network, Toronto
• Original Responsible Party: Same as current
• Current Study Sponsor: University Health Network, Toronto
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Amit Oza, M.D.; Princess Margaret Cancer Centre

• PRS Account: University Health Network, Toronto
• Verification Date: February 2024