Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05801263 |
| Other study ID # |
OVAMethy |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 24, 2023 |
| Est. completion date |
March 24, 2026 |
Study information
| Verified date |
March 2023 |
| Source |
Peking Union Medical College Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
In this study, cell-free DNA will be extracted from the blood of outpatient opportunistic
screening subjects, the methylation status of genes will be measured, and the test results
will be obtained. Histological sampling was performed by current clinical practice in
patients with clinical manifestations and corresponding examinations (e.g., abnormal uterine
bleeding, ovarian mass/cyst on ultrasound, elevated tumor markers) suggesting ovarian
lesions. Accuracy of screening for ovarian cancer based on histopathological analysis of
blood ctDNA methylation. A 12-month clinical follow-up of women with DNA methylation at risk
for ovarian cancer, including symptom analysis, physical examination, imaging studies
(ultrasound, CT, or MRI), surgery or (biopsy) pathology, and tumors such as ROMA Marker
determination. Collect 5ml of blood for methylation testing before treatment. For the
hospital for treatment follow-up, the scheme for collecting patient information includes
basic data (birthday, medical record number, height, weight, etc.), symptom analysis,
physical examination, imaging examination (ultrasound, CT or MRI), surgery or (biopsy)
pathology, Determination of tumor markers such as ROMA, as well as the use of main
therapeutic drugs and courses of treatment, time to recurrence, re-treatment plan and course
of treatment, time of death (such as those who died during the study), etc. Blood was
collected for methylation detection. The 5ml blood collection points were (1). Before
treatment (surgery/chemoradiotherapy/immunotherapy); (2). Follow-up visit one month after
treatment; (3). Follow-up 3rd and 6th after treatment, 9, and 12 months, and complete
follow-up cases and specimen collection before March 24, 2024.
