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Study of Biomarkers in Gynecological Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03420118
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : August 8, 2018
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Procedure: Tumor tissue collection Procedure: Blood draws Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular and Immunological Characterization of Gynecological Malignancies
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : December 21, 2022
Estimated Study Completion Date : December 21, 2023

Arm Intervention/treatment
Experimental: Tumor tissue and blood samples collection Procedure: Tumor tissue collection

Depending on the status of disease when participants join the study, a sample of tumor 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:

  • At anytime participants require a biopsy as a part of their cancer care, a sample of that tumor tissue will be collected.
  • New biopsies will be done to collect fresh tumor tissue each time participants' disease worsens.

Procedure: Blood draws

Blood samples will be collected at the following different times points:

  • 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

Primary Outcome Measures :
  1. Genomic and immune signatures in terms of progression free survival [ Time Frame: 5 years ]
  2. Genomic and immune signatures in terms of overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histological confirmation of gynecological malignancy (ovarian, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03420118

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Contact: Amit Oza, M.D. 416-946-2818

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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Amit Oza, M.D.    416-946-2818   
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto Identifier: NCT03420118     History of Changes
Other Study ID Numbers: VENUS
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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