Study of Biomarkers in Gynecological Cancers
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|ClinicalTrials.gov Identifier: NCT03420118|
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : August 8, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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:
Procedure: Blood draws
Blood samples will be collected at the following different times points:
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420118
|Contact: Amit Oza, M.D.||firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 1Z5|
|Contact: Amit Oza, M.D. 416-946-2818 email@example.com|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre|