Validation of OvaPrintTM using liquid biopsy cell-free DNA Methylation in women with adnexal masses
Study validating the sensitivity, specificity, and overall accuracy of the OvaPrint test to detect epithelial ovarian cancer in women with adnexal masses that are undergoing surgery or diagnostic procedure.
About This Study
Summary
The study aims to validate the analytical performance of the OvaPrint test, a liquid biopsy-based molecular diagnostic test. OvaPrint is a cfDNA methylation-based liquid biopsy test designed for cancer risk assessment to discriminate between High Grade Serous Ovarian Cancer (primarily early stage) and benign adnexal masses.
To be included in OvaPrint, participants must be / have:
- Able to understand study procedures and provide written informed consent
- Women with adnexal mass on imaging prior to enrollment for which a diagnostic procedure (including a biopsy) or surgery is planned
To be included in Ovaprint, participants must not be / have:
- History of any other invasive malignancy, except for: Completely removed in situ cervical intraepithelial neoplasia, non-melanoma skin cancer, or ductal carcinoma in situ
- Patients with prior cancer therapy (surgery, radiation, chemotherapy, targeted therapy, immunotherapy)
- Patients with high suspicion for malignant sex-cord stromal or germ cell ovarian tumor prior to surgery
- Inability to give informed consent
Keywords
ADC; Cancer; Chemotherapy; Gynecologic oncology; Ovarian cancer
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Dr. Erin Saks is the section chief of gynecologic oncology, as well as the medical director of the outpatient infusion center and cancer genetics program. She's board certified by the American Board of Obstetrics and Gynecology in obstetrics and gynecology and gynecologic oncology. She completed her fellowship at University of Virginia and completed her internship and residency with Brown University’s Alpert School of Medicine at Women and Infants hospital of Rhode Island. Dr. Saks joined the faculty of the department of obstetrics and gynecology in 2018 and is an assistant professor at the Virginia Tech Carilion School of Medicine.
Official title of study
Validation of OvaPrintTM using liquid biopsy cell-free DNA Methylation in women with adnexal masses
Funding mechanism
Industry sponsored by CPG Diagnostics