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

Last updated: September 12, 2024
Sponsor: Fujian Maternity and Child Health Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Intraepithelial Neoplasia

Treatment

Follow up

Clinical Study ID

NCT05282095
HPVZHCIN22021
  • Ages < 45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female, 18 years of age or older and 45 years of age or younger, with a desire toconceive;

  • Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within thepast 3 months, and has not undergone cervical surgery, physical, or medicationtreatment;

  • The lesion area under colposcopy is less than 50% of the total cervical area withinthe past 3 months;

  • Plans for 12-month follow-up observation for CIN2, with no surgical, physical, ormedication treatment if the disease does not progress;

  • Understands and voluntarily agrees to participate in the 12-month follow-up of thisstudy, and signs the informed consent form.

Exclusion

Exclusion Criteria:

  • Cervical status at the time of enrollment as determined by colposcopy within thepast 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-enrollfor sampling 3 days after cessation);

  • Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24hours after cessation);

  • Received treatment for genital tract infections, HPV, or other STD pathogens withinthe past month (can re-enroll one month after cessation of treatment);

  • Used antibiotics or vaginal microecological improvement products within the pastmonth (can re-enroll one month after cessation of use);

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Follow up
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Fujian Maternity and Child Health Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Longyan First Hospital

    Longyan, Fujian
    China

    Active - Recruiting

  • The Second Hospital of Longyan

    Longyan, Fujian
    China

    Active - Recruiting

  • Mindong Hospital of Ningde City

    Ningde, Fujian 352000
    China

    Site Not Available

  • Ningde Municipal Hospital of Ningde Normal University

    Ningde, Fujian 352100
    China

    Active - Recruiting

  • The Affiliated Hospital of Putian University

    Putian, Fujian
    China

    Active - Recruiting

  • The First Hospital of Putian City

    Putian, Fujian 351100
    China

    Active - Recruiting

  • Quanzhou First Hospital Afflicated to Fujian Medical University

    Quanzhou, Fujian 362000
    China

    Site Not Available

  • Sanming Second Hospital

    Sanming, Fujian
    China

    Active - Recruiting

  • Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University

    Xiamen, Fujian 361000
    China

    Site Not Available

  • Zhangzhou affiliated Hospital of Fujian Medical University

    Zhangzhou, Fujian 363000
    China

    Active - Recruiting

  • Gansu Provincial Maternal and Child Health Care Hospital

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Shenzhen Maternity and Child HealthCare Hospital

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Guiyang maternal and child health care hospital

    Guiyang, Guizhou
    China

    Active - Recruiting

  • Hubei Maternal and Child Health Care Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei
    China

    Active - Recruiting

  • Jiangxi maternal and Child Health Hospital

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Northwest Women's and Children's Hospital

    Xi'an, Shanxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang
    China

    Active - Recruiting

  • The First Hospital of Fuzhou City

    Fuzhou,
    China

    Active - Recruiting

  • Nanping Second Hospital

    Nanjing,
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.