Examining biomarkers in gynecological cancers
Molecular and Immunological Characterization of Gynecological Malignancies
This study is testing how certain biological markers in tumor and blood samples from women with gynecological cancers can help improve treatments and outcomes for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03420118 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 16 and older with a confirmed diagnosis of gynecological malignancy who are undergoing upfront surgery or radiation.
Not a fit: Patients who have previously received treatment for their cancer, such as neoadjuvant chemotherapy or radiation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more personalized and effective treatment options for patients with gynecological cancers.
How similar studies have performed: Other studies have shown promise in utilizing biomarkers for targeted therapies in cancer treatment, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.