RecruitingNot Applicable

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

China300 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cervical histopathology testing at baseline

Timeframe: Baseline

Cervical histopathology testing at 6-month follow-up

Timeframe: 6-month follow-up

Cervical histopathology testing at 12-month follow-up

Timeframe: 12-month follow-up

Human Papillomavirus (HPV) viral integration test at baseline

Timeframe: Baseline

Human Papillomavirus (HPV) viral integration test at 6-month follow-up

Timeframe: 6-month follow-up

Human Papillomavirus (HPV) viral integration test at 12-month follow-up

Timeframe: 12-month follow-up

Cervical cytology testing at baseline

Timeframe: Baseline

Trial details

NCT IDNCT05282095

SponsorFujian Maternity and Child Health Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Binhua Dong

+86-591-87558732 dbh18-jy@126.com

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.