Clinical trial NCT05282095: Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
Official title: Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Intraepithelial Neoplasia
HPV Infection
Virus Integration
HSIL, High Grade Squamous Intraepithelial Lesions
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 300
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ≤45 years old Chinese women with cervical histopathology for CIN2.

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.

Eligibility criteria: Inclusion Criteria:

* Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive;
* Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment;
* The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months;
* Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress;
* Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form.

Exclusion Criteria:

* Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone;
* Pregnant or lactating;
* History of malignant reproductive tract tumors;
* History of hysterectomy, cervical surgery, or pelvic radiation therapy;
* Physical therapy to the cervix within 24 months prior to enrollment;
* The subject has a severe immune system disease that is active;
* Long-term use of contraceptives within 12 months prior to enrollment;
* Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation);
* Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation);
* Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment);
* Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);

Primary outcomes:
measure: Cervical histopathology testing at baseline
timeFrame: Baseline
measure: Cervical histopathology testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: Cervical histopathology testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) viral integration test at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) viral integration test at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) viral integration test at 12-month follow-up
timeFrame: 12-month follow-up
measure: Cervical cytology testing at baseline
timeFrame: Baseline
measure: Cervical cytology testing at 3-month follow-up
timeFrame: 3-month follow-up
measure: Cervical cytology testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: Cervical cytology testing at 9-month follow-up
timeFrame: 9-month follow-up
measure: Cervical cytology testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at baseline
timeFrame: Baseline
measure: 16SrRNA sequencing of the vaginal secretions at 3-month follow-up
timeFrame: 3-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 6-month follow-up
timeFrame: 6-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 9-month follow-up
timeFrame: 9-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) genotyping tests at 3-month follow-up
timeFrame: 3-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at 9-month follow-up
timeFrame: 9-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Longyan
country: China
facility: Longyan First Hospital
state: Fujian
city: Longyan
country: China
facility: The Second Hospital of Longyan
state: Fujian
city: Ningde
country: China
facility: Ningde Municipal Hospital of Ningde Normal University
state: Fujian
city: Putian
country: China
facility: The First Hospital of Putian City
state: Fujian
city: Putian
country: China
facility: The Affiliated Hospital of Putian University
state: Fujian
city: Sanming
country: China
facility: Sanming Second Hospital
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou affiliated Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Maternal and Child Health Care Hospital
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Maternity and Child HealthCare Hospital
state: Guangdong
city: Guiyang
country: China
facility: Guiyang maternal and child health care hospital
state: Guizhou
city: Wuhan
country: China
facility: Hubei Maternal and Child Health Care Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Nanchang
country: China
facility: Jiangxi maternal and Child Health Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
city: Xi'an
country: China
facility: Northwest Women's and Children's Hospital
state: Shanxi
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: Fujian Maternal and Child Health Hospital
name: Pengming Sun
role: STUDY_CHAIR
References: