Study of Biomarkers in Gynecological Cancers

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jan 26, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how certain changes in genes and proteins can affect gynecological cancers, like ovarian or cervical cancer. Researchers want to learn more about these changes to understand how they influence cancer behavior and treatment responses. By understanding these factors, they hope to improve cancer care for patients now and in the future.

If you or someone you know has been diagnosed with a gynecological cancer and is at least 16 years old, you might be eligible to participate. Participants need to be undergoing surgery or radiation treatment and must agree to provide tissue and blood samples for research. During the study, you can expect to provide important information about your health, which will help scientists learn more about these cancers. It's important to note that patients with specific types of ovarian cancer are not eligible for this trial. This research could lead to better treatment options tailored to individual patients based on their unique cancer characteristics.

Gender

ALL

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