Study of Biomarkers in Gynecological Cancers

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    250
  • sponsor
    University Health Network, Toronto
Updated on 22 April 2021
cancer
cancer care

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.

Details
Condition Gynecologic Cancer
Treatment Tumor tissue collection, Blood draws
Clinical Study IdentifierNCT03420118
SponsorUniversity Health Network, Toronto
Last Modified on22 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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