Spots Global Cancer Trial Database for Prognostic Study of HPV Virus Integration in Women With HSIL
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Trial Identification
Brief Title: Prognostic Study of HPV Virus Integration in Women With HSIL
Official Title: Prognostic Study of Different HPV Virus Integration in Women With HSIL
Study ID: NCT05745597
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
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
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
Shijiazhuang Obstetrics and Gynecology Hospital, Shijiazhuang, Hebei, China
Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Maternal and Child Health Hospital of Hubei Province, Wuhan, Hubei, China
Contact Details
Name: Pengming Sun
Affiliation: Fujian Maternal and Child Health Hospital
Role: STUDY_CHAIR
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