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Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection:a Multi-center Cohort Study in China
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 cases/center) 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.
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
Mindong Hospital of Ningde City
Ningde, Fujian, China
Ningde Municipal Hospital of Ningde Normal University
Ningde, Fujian, China
The First Hospital of Putian City
Putian, Fujian, China
Quanzhou First Hospital Afflicated to Fujian Medical University
Quanzhou, Fujian, China
Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
Zhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
Longyan First Hospital
Longyan, China
Nanping Second Hospital
Nanjing, China
Sanming Second Hospital
Sanming, China
Start Date
January 1, 2022
Primary Completion Date
November 30, 2024
Completion Date
December 31, 2024
Last Updated
November 18, 2023
1,000
ESTIMATED participants
Follow up
OTHER
Lead Sponsor
Fujian Maternity and Child Health Hospital
NCT07428330
NCT07225530
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