Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-27
Brief Title:
Role of Methylation Test Triage in HPV Positive Women
Sponsor:
Obstetrics Gynecology Hospital of Fudan University
Organization:
Obstetrics Gynecology Hospital of Fudan University
Study Overview
Official Title:
Clinical Validation of ASTN1 DLX1 ITGA4 RXFP3 SOX17 ZNF671 Methylation in HPV Positive Women a Multi-center RCT From China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MTTRIHPW
Brief Summary:
The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status ASTN1 DLX1 ITGA4 RXFP3 SOX17 ZNF671 in triaging high-risk human papillomavirus infection The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening
Detailed Description:
The study is divided into two phases a baseline cross-sectional phase and a 1-year follow-up phase Women who meet the clinical endpoint ie histopathologically confirmed CIN2 after baseline colposcopybiopsy are withdrawn from the study Participants who do not meet the primary endpointtreat at baseline will invited to participate in the follow-up phase of the trial Participants included in the follow-up phase are underwent HPV cytology and methylation tests at 6 months and 1 year after baselineSimilar to the baseline phaseparticipants were referred to colposcopybiopsy if any of the cytology and HPV tests result is positive
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