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Prognostic Study of Different HPV Virus Integration in Women With HSIL
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.
A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, China
Longyan People's Hospital
Longyan, Fujian, China
Nanping Second Hospital
Nanping, Fujian, China
Mindong Hospital of Ningde City
Ningde, Fujian, China
Ningde City Hospital
Ningde, Fujian, China
Affiliated Hospital of Putian University
Putian, Fujian, China
Putian First Hospital
Putian, Fujian, China
Sanming Second Hospital
Sanming, Fujian, China
Shenzhen Maternity and child Healthcare Hospital
Shenzhen, Guangdong, China
Start Date
January 1, 2023
Primary Completion Date
September 30, 2025
Completion Date
October 31, 2025
Last Updated
February 27, 2023
1,000
ESTIMATED participants
Follow up
OTHER
Lead Sponsor
Fujian Maternity and Child Health Hospital
NCT07428330
NCT07225530
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