RecruitingNCT05801263

ctDNA Methylation for Epithelial Ovarian Cancer

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


Sponsor

Lei Li

Enrollment

5,000 participants

Start Date

Mar 24, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Ovarian cancer is one of the most dangerous and predominant gynecological cancers, with a high cancer-related mortality rate in women. However, current testing methods are still limited, and if detected early, patients have a five-year survival rate of 92%. Therefore, early diagnosis and detection are crucial for diagnosing and treating ovarian cancer. According to the results of the researchers' previous research, it has been found that CDO1 and HOXA9 genes are hypermethylated in ovarian cancer, and the expression of free DNA methylation in plasma can be used as one of the biomarkers for detection. In a single-center retrospective/prospective study, it has been demonstrated that the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and comparison with ovarian pathology results can achieve \>80% sensitivity and specificity. To further explore the application of methylation detection technology in ovarian cancer, the application value of non-invasive diagnosis and prognosis follow-up will be explored to clarify the clinical application value of DNA methylation for early detection of ovarian cancer in the real world. The investigators will conduct a prospective multi-center cohort study, referred to as the OVAMethy study, which will involve more than ten research centers and is expected to recruit more than 5,000 clinical subjects to test the methylation detection kit and histopathology further, ROMA index and imaging results, and sensitivity and specificity technical performance parameters.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a DNA-based blood test (ctDNA methylation analysis) can more accurately detect and monitor epithelial ovarian cancer during routine follow-up visits — potentially improving on current tests like CA125. **You may be eligible if:** - You are 18 or older - You are attending routine outpatient follow-up visits for ovarian cancer or suspected ovarian conditions - You are not currently receiving chemotherapy, radiation, or surgery for ovarian problems - You have pathological (tissue-confirmed) results related to your ovary - You have recent blood marker results (CA125, HE4) and imaging available - You are willing to provide a blood sample and sign consent **You may NOT be eligible if:** - You do not meet all inclusion criteria - Ovarian pathology or tissue results are not available - You withdraw from the study before completing required samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCDO1 and HOXA9 methylation assay

CDO1 and HOXA9 methylation assay in plasma circulating tumor cells


Locations(1)

Lei Li

Beijing, Beijing Municipality, China

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NCT05801263


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