Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05283239
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-02-17
Brief Title:
Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
Sponsor:
Fujian Maternity and Child Health Hospital
Organization:
Fujian Maternity and Child Health Hospital
Study Overview
Official Title:
Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infectiona Multi-center Cohort Study in China
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Clinically patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 need regular colposcopic biopsy to assess the outcome and progression of the disease A total of 1000 participants with persistent HR-HPV infection 100 casescenter were recruited from multiple centers and HPV integration status and vaginal flora diversity were sequenced at baseline 6th month 12th month and 24th month respectively through prospective cohort studies And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection
Detailed Description:
This study aims to 1 determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection 2 determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection 3 determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection and its prognostic value in women with LSIL and HSIL
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