Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
- Conditions
- HPV InfectionHSIL, High-Grade Squamous Intraepithelial LesionsLSIL, Low-Grade Squamous Intraepithelial LesionsVirus Integration
- Interventions
- Other: Follow up
- Registration Number
- NCT05283239
- Lead Sponsor
- Fujian Maternity and Child Health Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
- Non pregnant people with sexual history；
- Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
- No history of previous surgery at the cervical site.
- Asexual life, no vaginal medication or flushing before 72 hours of sampling.
- Within 8 weeks after pregnancy or postpartum.
- Patients with history of genital tract tumor.
- History of HPV vaccination.
- Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
- In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
- Use antibiotics or vaginal microecological improvement products in recent 1 month.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women with persistent HR-HPV infection Follow up In the enrollment, women with persistent HR-HPV infection for more than 18 months will be included in this study. All participants will be followed up at 6th month, 12th month, 18th month and 24th month after baseline of recruitment.
- Primary Outcome Measures
Name Time Method Cervical histopathology testing at baseline Baseline Cervical histopathology was performed at baseline for all participants.
Cervical histopathology testing at 6-month follow-up 6-month follow-up Cervical histopathology was performed at 6-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Cervical histopathology testing at 12-month follow-up 12-month follow-up Cervical histopathology was performed at 12-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Human Papillomavirus (HPV) virus integration test at 18-month follow-up 18-month follow-up Human Papillomavirus (HPV) virus integration test was performed at 18-month follow-up for all participants.
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up 6-month follow-up All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.
Cervical histopathology testing at 18-month follow-up 18-month follow-up Cervical histopathology was performed at 18-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Cervical histopathology testing at 24-month follow-up 24-month follow-up Cervical histopathology was performed at 24-month follow-up for cervical HR-HPV infection or cytology abnormalities women
Human Papillomavirus (HPV) virus integration test at baseline Baseline Human Papillomavirus (HPV) virus integration test was performed at baseline for all participants.
Human Papillomavirus (HPV) virus integration test at 12-month follow-up 12-month follow-up Human Papillomavirus (HPV) virus integration test was performed at 12-month follow-up for all participants.
Human Papillomavirus (HPV) virus integration test at 6-month follow-up 6-month follow-up Human Papillomavirus (HPV) virus integration test was performed at 6-month follow-up for all participants.
Human Papillomavirus (HPV) virus integration test at 24-month follow-up 24-month follow-up Human Papillomavirus (HPV) virus integration test was performed at 24-month follow-up for all participants.
Cervical cytology testing at baseline Baseline All participants were tested for cervical cytology at the time of baseline.
Cervical cytology testing at 6-month follow-up 6-month follow-up All participants were tested for Cervical cytology testing at the time of 6-month follow-up.
Cervical cytology testing at 12-month follow-up 12-month follow-up All participants were tested for Cervical cytology testing at the time of 12-month follow-up.
Cervical cytology testing at 18-month follow-up 18-month follow-up All participants were tested for Cervical cytology testing at the time of 18-month follow-up.
Cervical cytology testing at 24-month follow-up 24-month follow-up All participants were tested for Cervical cytology testing at the time of 24-month follow-up.
Human Papillomavirus (HPV) genotyping tests at baseline Baseline All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up 12-month follow-up All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.
Human Papillomavirus (HPV) genotyping tests at 18-month follow-up 18-month follow-up All participants underwent Human Papillomavirus (HPV) genotyping tests at 18-month follow-up.
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up 24-month follow-up All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.
- Secondary Outcome Measures
Name Time Method 16SrRNA sequencing of the vaginal secretions at 12-month follow-up 12-month follow-up All participants underwent vaginal secretion sequencing at 12-month follow-up.
16SrRNA sequencing of the vaginal secretions at baseline Baseline All participants underwent vaginal secretion sequencing at baseline.
16SrRNA sequencing of the vaginal secretions at 24-month follow-up 24-month follow-up All participants underwent vaginal secretion sequencing at 24-month follow-up.
16SrRNA sequencing of the vaginal secretions at 6-month follow-up 6-month follow-up All participants underwent vaginal secretion sequencing at 6-month follow-up.
16SrRNA sequencing of the vaginal secretions at 18-month follow-up 18-month follow-up All participants underwent vaginal secretion sequencing at 18-month follow-up.
Trial Locations
- Locations (11)
Fujian Maternity and Child Health Hospital
🇨🇳Fuzhou, Fujian, China
Longyan First Hospital
🇨🇳Longyan, China
Mindong Hospital of Ningde City
🇨🇳Ningde, Fujian, China
Shenzhen Maternity and child Healthcare Hospital
🇨🇳Shenzhen, China
Ningde Municipal Hospital of Ningde Normal University
🇨🇳Ningde, Fujian, China
Quanzhou First Hospital Afflicated to Fujian Medical University
🇨🇳Quanzhou, Fujian, China
The First Hospital of Putian City
🇨🇳Putian, Fujian, China
Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
🇨🇳Xiamen, Fujian, China
Sanming Second Hospital
🇨🇳Sanming, China
Zhangzhou affiliated Hospital of Fujian Medical University
🇨🇳Zhangzhou, Fujian, China
Nanping Second Hospital
🇨🇳Nanjing, China