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Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
Sponsor: Tongji Hospital
Summary
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
Official title: Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2026-07-01
Completion Date
2029-12-30
Last Updated
2026-05-18
Healthy Volunteers
No
Interventions
Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection. The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance.
Locations (1)
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China