Effect of HPV Integration on Prognosis of Young Women With CIN2 in China

Study Overview
=================
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.

Official Title
-----------------
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China

Conditions
-----------------
Cervical Intraepithelial Neoplasia, HPV Infection, Virus Integration, HSIL, High Grade Squamous Intraepithelial Lesions

Intervention / Treatment
-----------------
* Other: Follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women aged from 18-45 with histopathologically confirmed CIN2<br>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. | Other: Follow up<br>* Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical histopathology testing at baseline | Cervical histopathology was performed at baseline for all participants. | Baseline | 
| Cervical histopathology testing at 6-month follow-up | Cervical histopathology was performed at 6-month follow-up for all participants. | 6-month follow-up | 
| Cervical histopathology testing at 12-month follow-up | Cervical histopathology was performed at 12-month follow-up for all participants. | 12-month follow-up | 
| Human Papillomavirus (HPV) viral integration test at baseline | Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants. | 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. | 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. | 12-month follow-up | 
| Cervical cytology testing at baseline | All participants were tested for cervical cytology at the time of baseline. | Baseline | 
| Cervical cytology testing at 3-month follow-up | All participants were tested for cervical cytology at 3-month follow-up. | 3-month follow-up | 
| Cervical cytology testing at 6-month follow-up | All participants were tested for cervical cytology at 6-month follow-up | 6-month follow-up | 
| Cervical cytology testing at 9-month follow-up | All participants were tested for cervical cytology at 9-month follow-up | 9-month follow-up | 
| Cervical cytology testing at 12-month follow-up | All participants were tested for cervical cytology at 12-month follow-up | 12-month follow-up | 
| 16SrRNA sequencing of the vaginal secretions at baseline | All participants underwent vaginal secretion sequencing at baseline. | Baseline | 
| 16SrRNA sequencing of the vaginal secretions at 3-month follow-up | All participants underwent vaginal secretion sequencing at 3-month follow-up. | 3-month follow-up | 
| 16SrRNA sequencing of the vaginal secretions at 6-month follow-up | All participants underwent vaginal secretion sequencing at 6-month follow-up | 6-month follow-up | 
| 16SrRNA sequencing of the vaginal secretions at 9-month follow-up | All participants underwent vaginal secretion sequencing at 9-month follow-up | 9-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 | 12-month follow-up | 
| Human Papillomavirus (HPV) genotyping tests at baseline | All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline. | Baseline | 
| Human Papillomavirus (HPV) genotyping tests at 3-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up. | 3-month follow-up | 
| Human Papillomavirus (HPV) genotyping tests at 9-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up. | 9-month follow-up |