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Clinical Trial NCT05282095 for Cervical Intraepithelial Neoplasia, HPV Infection, Virus Integration, HSIL, High Grade Squamous Intraepithelial Lesions is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of HPV Integration on Prognosis of Young Women With CIN2 in China 300
Clinical Trial NCT05282095 is an observational study for Cervical Intraepithelial Neoplasia, HPV Infection, Virus Integration, HSIL, High Grade Squamous Intraepithelial Lesions that is recruiting. It started on 1 June 2022 with plans to enroll 300 participants. Led by Fujian Maternity and Child Health Hospital, it is expected to complete by 31 May 2026. The latest data from ClinicalTrials.gov was last updated on 19 September 2024.
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...Show More
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 with CIN2. 3) determine the relationship between the integration status of different HPV genes in young CIN2 women and the results of vaginal flora and cervical exfoliative cytology. A prospective cohort of 300 participant...Show More
Official Title
Effect of HPV Integration on Prognosis of Young Women With CIN2 in China: A Multi-center Cohort Study in China
Conditions
Cervical Intraepithelial NeoplasiaHPV InfectionVirus IntegrationHSIL, High Grade Squamous Intraepithelial LesionsPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- HPVZHCIN22021
NCT ID Number
Start Date (Actual)
2022-06-01
Last Update Posted
2024-09-19
Completion Date (Estimated)
2026-05-31
Enrollment (Estimated)
300
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cervical histopathology testing at baseline | Cervical histopathology was performed at baseline for all participants. | Baseline |
Cervical histopathology testing at 6-month follow-up | Cervical histopathology was performed at 6-month follow-up for all participants. | 6-month follow-up |
Cervical histopathology testing at 12-month follow-up | Cervical histopathology was performed at 12-month follow-up for all participants. | 12-month follow-up |
Human Papillomavirus (HPV) viral integration test at baseline | Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants. | Baseline |
Human Papillomavirus (HPV) viral integration test at 6-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants. | 6-month follow-up |
Human Papillomavirus (HPV) viral integration test at 12-month follow-up | Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants. | 12-month follow-up |
Cervical cytology testing at baseline | All participants were tested for cervical cytology at the time of baseline. | Baseline |
Cervical cytology testing at 3-month follow-up | All participants were tested for cervical cytology at 3-month follow-up. | 3-month follow-up |
Cervical cytology testing at 6-month follow-up | All participants were tested for cervical cytology at 6-month follow-up | 6-month follow-up |
Cervical cytology testing at 9-month follow-up | All participants were tested for cervical cytology at 9-month follow-up | 9-month follow-up |
Cervical cytology testing at 12-month follow-up | All participants were tested for cervical cytology at 12-month follow-up | 12-month follow-up |
16SrRNA sequencing of the vaginal secretions at baseline | All participants underwent vaginal secretion sequencing at baseline. | Baseline |
16SrRNA sequencing of the vaginal secretions at 3-month follow-up | All participants underwent vaginal secretion sequencing at 3-month follow-up. | 3-month follow-up |
16SrRNA sequencing of the vaginal secretions at 6-month follow-up | All participants underwent vaginal secretion sequencing at 6-month follow-up | 6-month follow-up |
16SrRNA sequencing of the vaginal secretions at 9-month follow-up | All participants underwent vaginal secretion sequencing at 9-month follow-up | 9-month follow-up |
16SrRNA sequencing of the vaginal secretions at 12-month follow-up | All participants underwent vaginal secretion sequencing at 12-month follow-up | 12-month follow-up |
Human Papillomavirus (HPV) genotyping tests at baseline | All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline. | Baseline |
Human Papillomavirus (HPV) genotyping tests at 3-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 3-month follow-up. | 3-month follow-up |
Human Papillomavirus (HPV) genotyping tests at 9-month follow-up | All participants underwent Human Papillomavirus (HPV) genotyping tests at 9-month follow-up. | 9-month follow-up |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Eligible Sexes
Female
- 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.
- 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);
Fujian Maternity and Child Health HospitalStudy Responsible Party
Binhua Dong, Principal Investigator, Principal Investigator, Fujian Maternity and Child Health Hospital
Study Central Contact
Contact: Binhua Dong, +86-591-87558732, [email protected]
Contact: Pengming Sun, +86-591-87558732, [email protected]
20 Study Locations in 1 Countries
Fujian
Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China
Binhua Dong, Contact, +8613599071900, [email protected]
Recruiting
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Peifang Chen, Contact
Recruiting
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Lihong Chen, Contact
Recruiting
Longyan First Hospital, Longyan, Fujian, China
Jinyong Wang, Contact
Recruiting
The Second Hospital of Longyan, Longyan, Fujian, China
Wenrong Huang, Contact
Recruiting
Ningde Municipal Hospital of Ningde Normal University, Ningde, Fujian, 352100, China
Wenfang Jin, Contact, +8618559336833
Recruiting
The First Hospital of Putian City, Putian, Fujian, 351100, China
Xianqian Chen, Contact, +8618559336833
Recruiting
The Affiliated Hospital of Putian University, Putian, Fujian, China
Lijun Li, Contact
Recruiting
Sanming Second Hospital, Sanming, Fujian, China
Yisheng Lin, Contact
Recruiting
Zhangzhou affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, 363000, China
Feifeng Shi, M.D, Contact, +8613960086066
Recruiting
Gansu
Gansu Provincial Maternal and Child Health Care Hospital, Lanzhou, Gansu, China
Xunyuan Tuo, Contact
Recruiting
Guangdong
Shenzhen Maternity and Child HealthCare Hospital, Shenzhen, Guangdong, China
Zheng Zheng, Contact
Recruiting
Guizhou
Guiyang maternal and child health care hospital, Guiyang, Guizhou, China
Juntao Wang, Contact
Recruiting
Hubei
Hubei Maternal and Child Health Care Hospital, Wuhan, Hubei, China
Hongning Cai, Contact
Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Yan Li, Contact
Recruiting
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Wei Zhang, Contact
Recruiting
Jiangxi
Jiangxi maternal and Child Health Hospital, Nanchang, Jiangxi, China
Ling Li, Contact
Recruiting
Shanghai Municipality
Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai Municipality, China
Xiaowen Pu, Contact
Recruiting
Shanxi
Northwest Women's and Children's Hospital, Xi’an, Shanxi, China
Hongwei Tan, Contact
Recruiting
Zhejiang
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China
Yutao Guan, Contact
Recruiting