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

Launched by FUJIAN MATERNITY AND CHILD HEALTH HOSPITAL · Mar 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the integration of the HPV virus affects the health outcomes of young women diagnosed with a condition called CIN2, which is a type of cervical pre-cancer. The researchers are looking to understand if checking for HPV integration can help predict how well these women will do over time. The study is taking place in several hospitals in China and involves about 300 women aged 18 to 45 who have recently been diagnosed with CIN2 or a related condition through a biopsy.

To participate, women need to be in the specified age range, not pregnant or nursing, and willing to undergo a 12-month follow-up without treatment if their condition stays the same. Participants will provide cervical samples for testing and will have regular check-ins to monitor their health. This study is important because it aims to improve the understanding and management of cervical health in young women, which can ultimately help in preserving their fertility and overall well-being.

Gender

FEMALE

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);