ctDNA Methylation Testing for Detecting Epithelial Ovarian Cancer: A Prospective Multicenter Cohort Study (OVAMethy Study)

In this study, cell-free DNA will be extracted from the blood of outpatient opportunistic screening subjects, the methylation status of genes will be measured, and the test results will be obtained. Histological sampling was performed by current clinical practice in patients with clinical manifestations and corresponding examinations (e.g., abnormal uterine bleeding, ovarian mass/cyst on ultrasound, elevated tumor markers) suggesting ovarian lesions. Accuracy of screening for ovarian cancer based on histopathological analysis of blood ctDNA methylation. A 12-month clinical follow-up of women with DNA methylation at risk for ovarian cancer, including symptom analysis, physical examination, imaging studies (ultrasound, CT, or MRI), surgery or (biopsy) pathology, and tumors such as ROMA Marker determination. Collect 5ml of blood for methylation testing before treatment. For the hospital for treatment follow-up, the scheme for collecting patient information includes basic data (birthday, medical record number, height, weight, etc.), symptom analysis, physical examination, imaging examination (ultrasound, CT or MRI), surgery or (biopsy) pathology, Determination of tumor markers such as ROMA, as well as the use of main therapeutic drugs and courses of treatment, time to recurrence, re-treatment plan and course of treatment, time of death (such as those who died during the study), etc. Blood was collected for methylation detection. The 5ml blood collection points were (1). Before treatment (surgery/chemoradiotherapy/immunotherapy); (2). Follow-up visit one month after treatment; (3). Follow-up 3rd and 6th after treatment, 9, and 12 months, and complete follow-up cases and specimen collection before March 24, 2024.