Using blood tests to detect ovarian cancer through DNA analysis
ctDNA Methylation Testing for Detecting Epithelial Ovarian Cancer: A Prospective Multicenter Cohort Study (OVAMethy Study)
This study is testing whether a blood test that looks at DNA changes can help find ovarian cancer earlier than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05801263 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the early detection of epithelial ovarian cancer by analyzing the methylation status of specific genes (CDO1 and HOXA9) in cell-free DNA extracted from blood samples. Participants will undergo blood collection and histological sampling based on clinical indications, with a follow-up period of 12 months to monitor symptoms and treatment outcomes. The study aims to validate the effectiveness of this non-invasive diagnostic method compared to traditional histopathological analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with pathological ovarian results who are not currently undergoing chemotherapy or surgical treatment.
Not a fit: Patients without ovarian pathology or those who are currently receiving treatment for ovarian lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve early detection rates of ovarian cancer, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results in using DNA methylation as a biomarker for ovarian cancer detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Lei Li — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.