NCT05282095 Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
| NCT ID | NCT05282095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Maternity and Child Health Hospital |
| Condition | Cervical Intraepithelial Neoplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
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);
Contact & Investigator
Pengming Sun
STUDY CHAIR
Fujian Maternal and Child Health Hospital
Frequently Asked Questions
Who can join the NCT05282095 clinical trial?
This trial is open to female participants only, up to 45 Years, studying Cervical Intraepithelial Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05282095 currently recruiting?
Yes, NCT05282095 is actively recruiting participants. Contact the research team at dbh18-jy@126.com for enrollment information.
Where is the NCT05282095 trial being conducted?
This trial is being conducted at Fuzhou, China, Fuzhou, China, Fuzhou, China, Longyan, China and 11 additional locations.
Who is sponsoring the NCT05282095 clinical trial?
NCT05282095 is sponsored by Fujian Maternity and Child Health Hospital. The principal investigator is Pengming Sun at Fujian Maternal and Child Health Hospital. The trial plans to enroll 300 participants.