RecruitingNCT05801276

ctDNA Methylation for Detecting Ovarian Cancer

Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer: A Clinical Trial in China


Sponsor

Lei Li

Enrollment

1,400 participants

Start Date

Mar 24, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Ovarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than 80% with intraperitoneal spread. The five-year survival rate for late detection is only 29%; on the contrary, if detected early, the five-year survival rate can reach 92%. Therefore, early diagnosis and detection are essential in diagnosing and treating ovarian cancer. Liquid biopsy has attracted widespread attention because of its non-invasive, real-time, and dynamic characteristics. Cell-free DNA in plasma can identify a small tumor burden well and reflect the clinical cancer information of cells.The role of hypermethylation in developing malignant tumors has received increasing attention. Methylation is one of epigenetics and plays a vital role in the occurrence and development of tumors. According to previous research basis of the researchers, it has been found that CDO1 and HOXA9 genes show hypermethylation in ovarian cancer, and they are considered one of the biomarkers for detection. Therefore, this study will further explore the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and compared with ovarian pathology results; the application of methylation detection technology in ovarian cancer/precancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-up.This study will involve three centers and is expected to enroll more than 1,400 clinical subjects, further examine the consistency of methylation detection kits with the histopathological examination, ROMA index, and Sanger sequencing results, and obtain sensitivity and specificity technical performance parameters.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a DNA-based blood test (ctDNA methylation analysis) can help detect ovarian cancer before or at the time of surgery for a pelvic or ovarian mass — potentially offering a more sensitive and accurate detection method than current blood tests. **You may be eligible if:** - You are 18 or older - You are scheduled for surgery to investigate a pelvic or ovarian mass - You have not yet received chemotherapy, radiation, or prior surgery for this condition - You have blood marker results (CA125, HE4) and imaging available - You are willing to provide a blood sample and sign consent - Patients with breast, lung, colon, cervical, or uterine cancer may also be enrolled for comparison **You may NOT be eligible if:** - You do not meet all inclusion criteria - You are withdrawing from the study - The investigator determines your sample should not be included 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_TESTMethylation assay

Methylation assay of CDO1 and HOXA9 genes in plasma circulating tumor DNA


Locations(1)

Lei Li

Beijing, Beijing Municipality, China

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NCT05801276


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