Effect of HPV Integration on Prognosis of Young Women With CIN2 in China
NCT ID: NCT05282095
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2022-06-01
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women aged from 18-45 with histopathologically confirmed CIN2
In the enrollment, women whose cervical histopathological results have been diagnosed as cervical intraepithelial neoplasia (CIN2) for the last 3 months with abnormal results will be included in this study. All participants will be followed up four, at 3th month, 6th month, 9th month and 12th month.
Follow up
Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up.
Interventions
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Follow up
Participants will be followed up at baseline, 3th, 6th, 9th and 12th months with HPV viral integration tests, HPV genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopies and biopsies will be performed on the participants at 6 - and 12-month follow-up.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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);
45 Years
FEMALE
No
Sponsors
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Fujian Maternity and Child Health Hospital
OTHER
Responsible Party
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Binhua Dong
Principal Investigator
Principal Investigators
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Pengming Sun
Role: STUDY_CHAIR
Fujian Maternal and Child Health Hospital
Locations
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Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Longyan First Hospital
Longyan, Fujian, China
The Second Hospital of Longyan
Longyan, Fujian, China
Ningde Municipal Hospital of Ningde Normal University
Ningde, Fujian, China
The First Hospital of Putian City
Putian, Fujian, China
The Affiliated Hospital of Putian University
Putian, Fujian, China
Sanming Second Hospital
Sanming, Fujian, China
Zhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
Gansu Provincial Maternal and Child Health Care Hospital
Lanzhou, Gansu, China
Shenzhen Maternity and Child HealthCare Hospital
Shenzhen, Guangdong, China
Guiyang maternal and child health care hospital
Guiyang, Guizhou, China
Hubei Maternal and Child Health Care Hospital
Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Jiangxi maternal and Child Health Hospital
Nanchang, Jiangxi, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
Northwest Women's and Children's Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Peifang Chen
Role: primary
Lihong Chen
Role: primary
Jinyong Wang
Role: primary
Wenrong Huang
Role: primary
Wenfang Jin
Role: primary
Xianqian Chen
Role: primary
Lijun Li
Role: primary
Yisheng Lin
Role: primary
Feifeng Shi, M.D
Role: primary
Xunyuan Tuo
Role: primary
Zheng Zheng
Role: primary
Juntao Wang
Role: primary
Hongning Cai
Role: primary
Yan Li
Role: primary
Wei Zhang
Role: primary
Ling Li
Role: primary
Xiaowen Pu
Role: primary
Hongwei Tan
Role: primary
Yutao Guan
Role: primary
References
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Zhang Y, Zhang Y, Hu T, Pu X, Dong B, Tuo X, Zou H, Zhang W, Lyu Q, Huang W, Xue H, Xu S, Osafo KS, Ren Y, Lin W, Su J, Huang X, Sun P. Effect of HPV integration on prognosis of young women with CIN2 in China: protocol for a multicentre prospective cohort study. BMJ Open. 2025 Apr 28;15(4):e093863. doi: 10.1136/bmjopen-2024-093863.
Other Identifiers
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HPVZHCIN22021
Identifier Type: -
Identifier Source: org_study_id
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