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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
RECRUITINGMindong Hospital of Ningde City
Ningde, Fujian, China
RECRUITINGNingde Municipal Hospital of Ningde Normal University
Ningde, Fujian, China
RECRUITINGThe First Hospital of Putian City
Putian, Fujian, China
RECRUITINGQuanzhou First Hospital Afflicated to Fujian Medical University
Quanzhou, Fujian, China
RECRUITINGXiamen Maternity and Child Health Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
RECRUITINGZhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
RECRUITINGLongyan First Hospital
Longyan, China
RECRUITINGNanping Second Hospital
Nanjing, China
RECRUITINGSanming Second Hospital
Sanming, China
RECRUITING...and 1 more locations
Cervical histopathology testing at baseline
Cervical histopathology was performed at baseline for all participants.
Time frame: Baseline
Cervical histopathology testing at 6-month follow-up
Cervical histopathology was performed at 6-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Time frame: 6-month follow-up
Cervical histopathology testing at 12-month follow-up
Cervical histopathology was performed at 12-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Time frame: 12-month follow-up
Cervical histopathology testing at 18-month follow-up
Cervical histopathology was performed at 18-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Time frame: 18-month follow-up
Cervical histopathology testing at 24-month follow-up
Cervical histopathology was performed at 24-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Time frame: 24-month follow-up
Human Papillomavirus (HPV) virus integration test at baseline
Human Papillomavirus (HPV) virus integration test was performed at baseline for all participants.
Time frame: Baseline
Human Papillomavirus (HPV) virus integration test at 6-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 6-month follow-up for all participants.
Time frame: 6-month follow-up
Human Papillomavirus (HPV) virus integration test at 12-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 12-month follow-up for all participants.
Time frame: 12-month follow-up
Human Papillomavirus (HPV) virus integration test at 18-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 18-month follow-up for all participants.
Time frame: 18-month follow-up
Human Papillomavirus (HPV) virus integration test at 24-month follow-up
Human Papillomavirus (HPV) virus integration test was performed at 24-month follow-up for all participants.
Time frame: 24-month follow-up
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 testing at the time of 6-month follow-up.
Time frame: 6-month follow-up
Cervical cytology testing at 12-month follow-up
All participants were tested for Cervical cytology testing at the time of 12-month follow-up.
Time frame: 12-month follow-up
Cervical cytology testing at 18-month follow-up
All participants were tested for Cervical cytology testing at the time of 18-month follow-up.
Time frame: 18-month follow-up
Cervical cytology testing at 24-month follow-up
All participants were tested for Cervical cytology testing at the time of 24-month follow-up.
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 18-month follow-up
All participants underwent Human Papillomavirus (HPV) genotyping tests at 18-month follow-up.
Time frame: 18-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
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 18-month follow-up
All participants underwent vaginal secretion sequencing at 18-month follow-up.
Time frame: 18-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
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