Clinical trial · Observational
ctDNA Methylation for Epithelial Ovarian Cancer
ctDNA Methylation Testing for Detecting Epithelial Ovarian Cancer: A Prospective Multicenter Cohort Study (OVAMethy Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CA125 | — | UNRESOLVED | — |
| Circulating Tumor DNA | — | UNRESOLVED | — |
| DNA Methylation | — | UNRESOLVED | — |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Human Epididymis Protein 4 | — | UNRESOLVED | — |
| Imaging Evaluation | — | UNRESOLVED | — |
| Non-invasive Diagnosis | — | UNRESOLVED | — |
| Survival Prognosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDO1 and HOXA9 methylation assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Diagnostic sensitivity
- timeFrame
- One month
- description
- Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer
- measure
- Diagnostic specificity
- timeFrame
- One month
- description
- Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer
Secondary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- Two years
- description
- Progression-free survival after the last treatment for cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Outpatient routine follow-up population * Age is greater than or equal to 18 years * Not receiving any chemotherapy, physical therapy, or surgical treatment for ovarian lesions * Wtih pathological ovarian results * Willing to be tested and signed an informed consent form * With available data of plasma CA125, Human epididymis protein 4 and effective imaging results Exclusion Criteria: * Not meeting all the including criteria * WithoutoOvarian pathology or surgical pathology information could not be obtained * A sample of patients withdrawing from the trial * Samples that the investigator believes should be excluded from this trial
References
Publications (0)
Data not yet available