Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
- Conditions
- Cervical Intraepithelial NeoplasiaHSIL, High Grade Squamous Intraepithelial LesionsVirus IntegrationHPV Infection
- Interventions
- Other: Follow up
- Registration Number
- NCT05282095
- Lead Sponsor
- Fujian Maternity and Child Health Hospital
- Brief Summary
Clinically, cervical precancerous lesion is one of the important diseases that endanger the life safety and fertility of young women. Women with histopathologically confirmed CIN2 need regular HPV, cervical cytology, and colposcopic biopsy if necessary to assess the outcome and progression of the disease. In this study, we intend to visit Fujian Maternal and Child Health Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science \& Technology and other hospitals, including 300 CIN2 participants aged 45 and below diagnosed by histopathology, and collect the remaining cervical secretions and cervical exfoliated cell samples after clinical examination, even if you do not participate in this clinical study. In clinical diagnosis, treatment and follow-up, it is also necessary to collect the above specimens for relevant medical tests. Therefore, it is of great clinical and scientific significance to explore the role of HPV integrated detection in predicting the prognosis of young women with CIN2.
- Detailed Description
This study aims to:1) determine the correlation between HPV integration and natural outcome in young CIN2 women. 2) determine the prognostic value of different HPV integration status in young women with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participants under 45 years of age with histopathologically confirmed CIN2 was recruited from multiple centers, and HPV integration status, HPV infection status, cervical cytology, and vaginal flora diversity sequencing were performed at enrollment, 3 months, 6 months, 9 months, and 12 months. The purpose of this study was to evaluate the effect of HPV integration status and flora changes on the outcome and progression of CIN2 women, and to evaluate the correlation between HPV integration status and cervical cytology results.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Women ≤45 years of age with a sexual history.
- Young woman with histopathologically confirmed CIN2.
- No history of cervical conization or total hysterectomy, etc.
- No sexual experience, vaginal medication or drug flushing within 72 hours before sampling.
- Pregnant and lactating women.
- 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 aged from 18-45 with histopathologically confirmed CIN2 Follow up In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up four, at 3th month, 6th month, 9th month and 12th month.
- Primary Outcome Measures
Name Time Method Cervical cytology testing at 3-month follow-up 3-month follow-up All participants were tested for cervical cytology at 3-month follow-up.
Cervical cytology testing at 6-month follow-up 6-month follow-up All participants were tested for cervical cytology at 6-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 3-month follow-up 3-month follow-up All participants underwent vaginal secretion sequencing at 3-month follow-up.
Cervical histopathology testing at baseline Baseline Cervical histopathology was performed at baseline for all participants.
Human Papillomavirus (HPV) viral integration test at baseline Baseline Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.
Cervical cytology testing at 9-month follow-up 9-month follow-up All participants were tested for cervical cytology at 9-month follow-up
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
Cervical histopathology testing at 6-month follow-up 6-month follow-up Cervical histopathology was performed at 6-month follow-up for all participants.
Human Papillomavirus (HPV) viral integration test at 6-month follow-up 6-month follow-up Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.
Cervical cytology testing at baseline Baseline All participants were tested for cervical cytology at the time of baseline.
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
Human Papillomavirus (HPV) genotyping tests at 3-month follow-up 3-month follow-up All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up.
Cervical histopathology testing at 12-month follow-up 12-month follow-up Cervical histopathology was performed at 12-month follow-up for all participants.
Human Papillomavirus (HPV) viral integration test at 12-month follow-up 12-month follow-up Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.
Cervical cytology testing at 12-month follow-up 12-month follow-up All participants were tested for cervical cytology at 12-month follow-up
16SrRNA sequencing of the vaginal secretions at 9-month follow-up 9-month follow-up All participants underwent vaginal secretion sequencing at 9-month follow-up
Human Papillomavirus (HPV) genotyping tests at 9-month follow-up 9-month follow-up All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up.
Human Papillomavirus (HPV) genotyping tests at baseline Baseline All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Fujian Maternity and Child Health Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Longyan First Hospital
🇨🇳Longyan, Fujian, China
The Second Hospital of Longyan
🇨🇳Longyan, Fujian, China
Ningde Municipal Hospital of Ningde Normal University
🇨🇳Ningde, Fujian, China
The First Hospital of Putian City
🇨🇳Putian, Fujian, China
The Affiliated Hospital of Putian University
🇨🇳Putian, Fujian, China
Sanming Second Hospital
🇨🇳Sanming, Fujian, China
Zhangzhou affiliated Hospital of Fujian Medical University
🇨🇳Zhangzhou, Fujian, China
Gansu Provincial Maternal and Child Health Care Hospital
🇨🇳Lanzhou, Gansu, China
Shenzhen Maternity and Child HealthCare Hospital
🇨🇳Shenzhen, Guangdong, China
Guiyang maternal and child health care hospital
🇨🇳Guiyang, Guizhou, China
Hubei Maternal and Child Health Care Hospital
🇨🇳Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Jiangxi maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, Shanghai, China
Northwest Women's and Children's Hospital
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China