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

Fujian Maternity and Child Health Hospital

Status: Enrolling

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

Treatments: Other: Follow up

Study type: Observational

Funder types: Other

Identifiers

NCT05282095

HPVZHCIN22021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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);

Trial design

300 participants in 1 patient group

Women aged from 18-45 with histopathologically confirmed CIN2

Description:

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.

Treatment:

Other: Follow up