RecruitingNCT05282095

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

Sponsor

Fujian Maternity and Child Health Hospital

Enrollment

300 participants

Start Date

Jun 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

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

Sex: FEMALEMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study follows young Chinese women (18–45) who have been diagnosed with a moderate cervical pre-cancer (called CIN2 or HSIL) and want to preserve their fertility. Rather than immediately treating the lesion, researchers monitor it over 12 months to see whether having HPV integrated into the cells' DNA affects how likely the lesion is to grow or go away on its own. **You may be eligible if...** - You are a woman aged 18–45 who wants to have children in the future - You were recently diagnosed with moderate cervical pre-cancer (CIN2) and have not yet had any treatment - Your lesion covers less than half of the cervix - You are willing to attend follow-up visits for 12 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had previous cervical surgery, hysterectomy, or pelvic radiation - You have a serious immune system disease - You have had sexual intercourse or vaginal treatments in the 24–72 hours before sampling Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERFollow 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.

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 Municipality, China

Northwest Women's and Children's Hospital

Xi’an, Shanxi, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05282095

Related Trials

Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis

NCT070291528 locations

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

NCT074283301 location

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(20)

Related Trials

Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

Feasibility of HPV Self-Collection Kits for Cervical Cancer Screening

Point of Care - Triage and Treatment for Cervical Pre-cancer

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia