Detecting ovarian cancer using blood tests for DNA changes
Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer: A Clinical Trial in China
This study is testing a new blood test that looks for DNA changes to see if it can help find ovarian cancer earlier in women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05801276 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the early detection of epithelial ovarian cancer through the analysis of circulating tumor DNA (ctDNA) methylation patterns in plasma samples. It consists of two phases: the Clinical Performance Validation phase, which evaluates the effectiveness of assessment reagents against standard histopathological examinations, and the Assay Accuracy Verification phase, which uses Sanger sequencing to compare the accuracy of methylation detection methods. By focusing on non-invasive liquid biopsy techniques, the study seeks to enhance diagnostic capabilities for ovarian cancer, potentially leading to earlier treatment interventions.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older who are preparing for surgical treatment of pelvic or adnexal masses and have not undergone prior chemotherapy or surgery for ovarian lesions.
Not a fit: Patients who are currently receiving chemotherapy, physical therapy, or surgical treatment for ovarian lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve early detection rates of ovarian cancer, leading to better patient outcomes and survival rates.
How similar studies have performed: Other studies utilizing liquid biopsy and ctDNA methylation for cancer detection have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ready for surgical treatment for pelvic mass or adnexal mass * Age is greater than or equal to 18 years * Not receiving any chemotherapy, physical therapy, or surgical treatment for ovarian lesions * With ovarian pathology * Willing to be tested and signed an informed consent form * With available data of plasma CA125, Human epididymis protein 4 and effective imaging results * The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas Exclusion Criteria: * Not meeting all the including criteria * 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.