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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
RECRUITINGLongyan First Hospital
Longyan, Fujian, China
ACTIVE_NOT_RECRUITINGLongyan People's Hospital
Longyan, Fujian, China
ACTIVE_NOT_RECRUITINGNanping Second Hospital
Nanping, Fujian, China
RECRUITINGMindong Hospital of Ningde City
Ningde, Fujian, China
RECRUITINGNingde City Hospital
Ningde, Fujian, China
ACTIVE_NOT_RECRUITINGAffiliated Hospital of Putian University
Putian, Fujian, China
ACTIVE_NOT_RECRUITINGPutian First Hospital
Putian, Fujian, China
RECRUITINGSanming Second Hospital
Sanming, Fujian, China
RECRUITINGShenzhen Maternity and child Healthcare Hospital
Shenzhen, Guangdong, China
RECRUITING...and 3 more locations
Cervical cytology testing at baseline
All participants were tested for cervical cytology at the time of baseline.
Time frame: Baseline
Cervical cytology testing at 6-month follow-up
All participants were tested for cervical cytology at 6-month follow-up for all participants.
Time frame: 6-month follow-up
Cervical cytology testing at 12-month follow-up
All participants were tested for cervical cytology at 12-month follow-up
Time frame: 12-month follow-up
Cervical cytology testing at 24-month follow-up
Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 24-month follow-up
Time frame: 24-month follow-up
16SrRNA sequencing of the vaginal secretions at baseline
All participants underwent vaginal secretion sequencing at baseline.
Time frame: Baseline
16SrRNA sequencing of the vaginal secretions at 6-month follow-up
All participants underwent vaginal secretion sequencing at 6-month follow-up
Time frame: 6-month follow-up
16SrRNA sequencing of the vaginal secretions at 12-month follow-up
All participants underwent vaginal secretion sequencing at 12-month follow-up
Time frame: 12-month follow-up
16SrRNA sequencing of the vaginal secretions at 24-month follow-up
All participants underwent vaginal secretion sequencing at 24-month follow-up
Time frame: 24-month follow-up
Human Papillomavirus (HPV) viral integration test at baseline
Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.
Time frame: Baseline
Human Papillomavirus (HPV) viral integration test at 6-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.
Time frame: 6-month follow-up
Human Papillomavirus (HPV) viral integration test at 12-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.
Time frame: 12-month follow-up
Human Papillomavirus (HPV) viral integration test at 24-month follow-up
Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants.
Time frame: 24-month follow-up
Human Papillomavirus (HPV) genotyping tests at baseline
All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
Time frame: Baseline
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.
Time frame: 6-month follow-up
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.
Time frame: 12-month follow-up
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.
Time frame: 24-month follow-up
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