Phase 2 Study to Detect Ovarian Cancer Using DNA from Uterine Lavage and Blood Proteins

What this Trial Is About

Researchers are studying a new way to detect ovarian cancer early by analyzing DNA found in a uterine wash and proteins in the blood. The study includes women who are scheduled for surgery due to suspected ovarian cancer or those with a BRCA1 or BRCA2 mutation undergoing preventive surgery. The goal is to find tests that can accurately distinguish ovarian cancer cases from benign ovarian conditions, potentially leading to earlier detection and fewer late-stage diagnoses. Participants are divided into two groups one with about 200 women having surgery for suspected ovarian cancer and another with about 50 women with BRCA mutations undergoing risk-reducing surgery. Before surgery, blood samples are taken, and during surgery, a uterine lavage is performed to collect samples. These samples are sent to multiple labs for DNA and protein analysis, including specialized sequencing and protein assays. During the study, participants will have blood draws up to 31 days before surgery and a uterine lavage during surgery. Researchers will analyze genetic mutations and protein levels in the collected samples and compare results with surgical pathology. The primary outcome measures are genomic and protein biomarkers detected from enrollment through pathology results. Samples will also be stored for future research. The study aims to improve early ovarian cancer detection with ongoing monitoring until pathology results are available.

Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer