Spots Global Cancer Trial Database for Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
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Trial Identification
Brief Title: Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
Official Title: Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
Study ID: NCT05283239
Interventions
Study Description
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 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.
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Shenzhen Maternity and child Healthcare Hospital, Shenzhen, , China
Contact Details
Name: Binhua Dong, MD
Affiliation: Fujian Maternity and Child Health Hospital
Role: STUDY_CHAIR
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