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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Intraepithelial Neoplasia; HPV Infection; Virus Integration; HSIL, High Grade Squamous Intraepithelial Lesions
• Intervention / Treatment: Other: Follow up

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Binhua Dong; Phone Number: +86-591-87558732; Email: dbh18-jy@126.com
• Study Contact Backup: Name: Pengming Sun; Phone Number: +86-591-87558732; Email: sunfemy@hotmail.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Maternity and Child Health Hospital
      • Contact: Binhua Dong; Phone Number: +8613599071900; Email: dbh18-jy@126.com
    • Fuzhou, Fujian, China
      • Recruiting
      • The First Affiliated Hospital Of Fujian Medical University
      • Contact: Lihong Chen
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Peifang Chen
    • Longyan, Fujian, China
      • Recruiting
      • Longyan First Hospital
      • Contact: Jinyong Wang
    • Longyan, Fujian, China
      • Recruiting
      • The Second Hospital of Longyan
      • Contact: Wenrong Huang
    • Ningde, Fujian, China, 352100
      • Recruiting
      • Ningde Municipal Hospital of Ningde Normal University
      • Contact: Wenfang Jin; Phone Number: +8618559336833
    • Putian, Fujian, China, 351100
      • Recruiting
      • The First Hospital of Putian City
      • Contact: Xianqian Chen; Phone Number: +8618559336833
    • Putian, Fujian, China
      • Recruiting
      • The Affiliated Hospital of Putian University
      • Contact: Lijun Li
    • Sanming, Fujian, China
      • Recruiting
      • Sanming Second Hospital
      • Contact: Yisheng Lin
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Zhangzhou Affiliated Hospital of Fujian Medical University
      • Contact: Feifeng Shi, M.D; Phone Number: +8613960086066
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Gansu Provincial Maternal and Child Health Care Hospital
      • Contact: Xunyuan Tuo
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Maternity and Child Healthcare Hospital
      • Contact: Zheng Zheng
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Guiyang maternal and child health care hospital
      • Contact: Juntao Wang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Wei Zhang
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
      • Contact: Yan Li
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Maternal and Child Health Care Hospital
      • Contact: Hongning Cai
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Maternal and Child Health Hospital
      • Contact: Ling Li
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai First Maternity and Infant Hospital
      • Contact: Xiaowen Pu
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • Northwest Women's and Children's Hospital
      • Contact: Hongwei Tan
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Recruiting
      • The first affiliated Hospital of Ningbo University
      • Contact: Yutao Guan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

≤45 years old Chinese women with cervical histopathology for CIN2.

Description

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);

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women aged from 18-45 with histopathologically confirmed CIN2; 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; 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.

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 cytology testing at baseline	All participants were tested for cervical cytology at the time of baseline.	Baseline
Human Papillomavirus (HPV) genotyping tests at baseline	All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.	Baseline
16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	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 6-month follow-up	All participants were tested for cervical cytology at 6-month follow-up	6-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 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 12-month follow-up	All participants underwent vaginal secretion sequencing at 12-month follow-up	12-month follow-up
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 9-month follow-up	All participants were tested for cervical cytology at 9-month follow-up	9-month follow-up
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 9-month follow-up	All participants underwent vaginal secretion sequencing at 9-month follow-up	9-month follow-up
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

Collaborators and Investigators

• Sponsor: Fujian Maternity and Child Health Hospital
• Investigators: Study Chair: Pengming Sun, Fujian Maternal and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Precancerous Conditions; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Dysplasia; Papillomavirus Infections
• Other Study ID Numbers: HPVZHCIN22021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No