Status:
RECRUITING
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
Lead Sponsor:
Fujian Maternity and Child Health Hospital
Conditions:
Cervical Intraepithelial Neoplasia
HPV Infection
Eligibility:
FEMALE
Up to 45 years
Brief 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, ce...
Detailed 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05282095
Start Date
June 1 2022
End Date
May 31 2026
Last Update
September 19 2024
Active Locations (20)
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1
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China, 350001
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
4
Longyan First Hospital
Longyan, Fujian, China