Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801276
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-24
Brief Title:
ctDNA Methylation for Detecting Ovarian Cancer
Sponsor:
Lei Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Exploration of Plasma CDO1 and HOXA9 DNA Methylation for Detecting Epithelial Ovarian Cancer A Clinical Trial in China
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 cellsThe 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 cancerprecancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-upThis study will involve three centers and is expected to enroll more than 1400 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
Detailed Description:
This study has two phases the Clinical Performance Validation cohort and the Assay Accuracy Verification cohort
The Clinical Performance Validation phase of this study will assess the reagents to detect plasma samples patients undergo routine examinations by clinical trial institutions including but not limited to tumor markers and histopathological examinations The clinical performance of the assessment reagents was systematically evaluated by evaluating the consistency between the test results of the assessment reagents and the histopathological examination results as well as the surface of the ROMA index and the histopathological examination results
During the Assay Accuracy Verification phase of this study a part of the qualified samples was randomly selected The Sanger sequencing method was used as a comparison method to evaluate the detection accuracy of the test reagents for detecting the methylation of CDO1 and HOXA9 genes
The Clinical Performance Validation phase of this study will assess the reagents to detect plasma samples patients undergo routine examinations by clinical trial institutions including but not limited to tumor markers and histopathological examinations The clinical performance of the assessment reagents was systematically evaluated by evaluating the consistency between the test results of the assessment reagents and the histopathological examination results as well as the surface of the ROMA index and the histopathological examination results
During the Assay Accuracy Verification phase of this study a part of the qualified samples was randomly selected The Sanger sequencing method was used as a comparison method to evaluate the detection accuracy of the test reagents for detecting the methylation of CDO1 and HOXA9 genes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None