Study of HPV Integration Impact on Prognosis in Women 18 to 45 Years Old with CIN2 in China

What this Trial Is About

Researchers are studying the role of HPV integration in predicting the prognosis of young women aged 45 and below diagnosed with cervical intraepithelial neoplasia grade 2 CIN2, a precancerous cervical condition. The study aims to explore the correlation between HPV integration, vaginal flora changes, and cervical cytology results to better understand disease progression and outcomes. This multi-center cohort study includes 300 participants from hospitals in China, focusing on the natural course of CIN2 without surgical or medication treatment when appropriate. Participants will be followed at enrollment and then at 3, 6, 9, and 12 months. At these visits, HPV viral integration tests, HPV genotyping tests, cervical cytology, and sequencing of vaginal secretions will be performed. Colposcopies and biopsies will be conducted at 6 and 12 months to closely monitor cervical tissue changes. The study observes participants under regular clinical follow-up without intervention unless disease progression occurs. During the study, participants will provide cervical secretions and exfoliated cell samples for testing. Researchers will assess cervical histopathology, HPV integration status, cervical cytology, vaginal flora diversity, and HPV genotyping at multiple time points. Outcomes measured include cervical tissue changes and HPV-related markers to evaluate the diseases natural course. The study lasts 12 months with scheduled clinical visits and laboratory assessments to monitor participants cervical health and HPV status throughout this period.

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