NCT03420118

Study of Biomarkers in Gynecological Cancers

Molecular and Immunological Characterization of Gynecological Malignancies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-21
• Primary completion: 2026-12-21
• Completion: 2027-12-21
• First posted: 2018-02-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: Canada