Impact of HPV Integration on Prognosis in Young Women with CIN2

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

This study is trying to see how HPV integration affects the outcomes of cervical changes in young women with CIN2 to help guide their treatment.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: N/A to 45 Years
• Sex: Female
• Sponsor: Fujian Maternity and Child Health Hospital (other)
• Drugs / interventions: radiation
• Locations: 20 sites (Fuzhou, Fujian and 19 other locations)
• Trial ID: NCT05282095 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between HPV integration and the natural outcomes of cervical intraepithelial neoplasia (CIN2) in young women aged 45 and below. A cohort of 300 participants diagnosed with CIN2 will be followed for 12 months, during which cervical secretions and exfoliated cell samples will be collected for analysis. The study aims to assess the prognostic value of HPV integration status and its correlation with cervical cytology and vaginal flora diversity. The findings could provide insights into the progression of CIN2 and inform clinical management strategies.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 45 with a recent diagnosis of CIN2 or HSIL and a desire to conceive.

Not a fit: Patients who have undergone cervical surgery or have a history of malignant reproductive tract tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of CIN2 prognosis and improve management strategies for young women at risk.

How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored HPV integration and its implications in cervical lesions with varying degrees of success.

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);

Where this trial is running

Fuzhou, Fujian and 19 other locations

• Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
• Longyan First Hospital — Longyan, Fujian, China (RECRUITING)
• The Second Hospital of Longyan — Longyan, Fujian, China (RECRUITING)
• Ningde Municipal Hospital of Ningde Normal University — Ningde, Fujian, China (RECRUITING)
• The First Hospital of Putian City — Putian, Fujian, China (RECRUITING)
• The Affiliated Hospital of Putian University — Putian, Fujian, China (RECRUITING)
• Sanming Second Hospital — Sanming, Fujian, China (RECRUITING)
• Zhangzhou affiliated Hospital of Fujian Medical University — Zhangzhou, Fujian, China (RECRUITING)
• Gansu Provincial Maternal and Child Health Care Hospital — Lanzhou, Gansu, China (RECRUITING)
• Shenzhen Maternity and Child HealthCare Hospital — Shenzhen, Guangdong, China (RECRUITING)
• Guiyang maternal and child health care hospital — Guiyang, Guizhou, China (RECRUITING)
• Hubei Maternal and Child Health Care Hospital — Wuhan, Hubei, China (RECRUITING)
• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (RECRUITING)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (RECRUITING)
• Jiangxi maternal and Child Health Hospital — Nanchang, Jiangxi, China (RECRUITING)
• Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• Northwest Women's and Children's Hospital — Xi’an, Shanxi, China (RECRUITING)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Binhua Dong

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