Study of Methylated DNA Markers for Early Detection of Endometrial, Ovarian, and Cervical Cancers Using Vaginal Fluid and Blood Samples

What this Trial Is About

Researchers are developing a test to detect gynecologic cancers, including endometrial, ovarian, and cervical cancers, by identifying specific methylated DNA markers and high-risk human papilloma virus in vaginal fluid and blood plasma. The goal is to improve early detection, especially for women presenting with abnormal uterine bleeding or postmenopausal bleeding, symptoms often linked to these cancers or their precursors. Early detection is crucial to increase the chances of cure and reduce the need for invasive procedures. The study includes multiple groups of women with different gynecologic conditions such as abnormal uterine bleeding, biopsy-confirmed endometrial or ovarian cancer, cervical abnormalities, benign uterine conditions, and healthy controls. Participants will provide vaginal fluid samples collected by a healthcare provider and blood samples before any exams or procedures. This observational study involves testing these samples for cancer-specific markers to develop and validate predictive models for detecting these cancers. Participants will undergo sample collection and clinical evaluations as part of their usual care, including biopsies or surgery when indicated. Researchers will assess the ability of the methylated DNA marker panels to identify cancer and precancerous conditions with high specificity. The study also monitors false positive rates among women with benign conditions. The total participation time varies depending on the patient group, with key outcomes measured over an 18-month period.

Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer