Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection

The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are: How well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes? Researchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay. Participants will: Provide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis

NCT Number	NCT07593833
Lead Sponsor	Tongji Hospital Collaborators: Women's Hospital School Of Medicine Zhejiang University, The Affiliated Hospital of Qingdao University, Shanghai First Maternity and Infant Hospital, The First Affiliated Hospital of Soochow University, Xiangyang Central Hospital, The First Hospital of Jilin University, Renmin Hospital of Wuhan University, General Hospital of Ningxia Medical University, Wuhan Central Hospital, LanZhou University, Tongji Hospital affiliated to Tongji University, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Conditions	Ovarian Neoplasms, Ovarian Cancer, Early Detection of Cancer
Enrollment	1,000 participants
Start Date	2026-07-01
Primary Completion	2029-06-30 (estimated)
Study Completion	2029-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-18