Examining biomarkers in gynecological cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on understanding the biological markers associated with gynecological cancers, including ovarian, uterine, and cervical cancers. It aims to collect tumor tissue and blood samples from patients undergoing surgery or radiation to analyze genetic and protein changes that may influence treatment responses. By identifying these biomarkers, the research seeks to enhance targeted therapies and improve patient outcomes. The study is designed for patients who are treatment naïve and have a confirmed diagnosis of gynecological malignancy.

Why it matters

Who can join: the full rules

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

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Amit Oza, M.D. — Princess Margaret Cancer Centre
• Study coordinator: Amit Oza, M.D.
• Email: amit.oza@uhn.ca
• Phone: 416-946-2818

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.