Prognostic Study of HPV Virus Integration in Women With HSIL
NCT ID: NCT05745597
Last Updated: 2023-02-27
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
1000 participants
OBSERVATIONAL
2023-01-01
2025-10-31
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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HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology
In this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24.
Follow up
Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.
Interventions
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Follow up
Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.
Eligibility Criteria
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Inclusion Criteria
* No surgical treatment or conization only;
* Obtain informed consent.
Exclusion Criteria
* Patients with a history of genital tract cancer;
* Previous history of hysterectomy, cervical surgery or pelvic radiotherapy;
* Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month;
* Use of antibiotics or vaginal microecological improvement products in the past 1 month.
FEMALE
No
Sponsors
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Fujian Maternity and Child Health Hospital
OTHER
Responsible Party
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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
Longyan First Hospital
Longyan, Fujian, China
Longyan People's Hospital
Longyan, Fujian, China
Nanping Second Hospital
Nanping, Fujian, China
Mindong Hospital of Ningde City
Ningde, Fujian, China
Ningde City Hospital
Ningde, Fujian, China
Affiliated Hospital of Putian University
Putian, Fujian, China
Putian First Hospital
Putian, Fujian, China
Sanming Second Hospital
Sanming, Fujian, China
Shenzhen Maternity and child Healthcare Hospital
Shenzhen, Guangdong, China
Shijiazhuang Obstetrics and Gynecology Hospital
Shijiazhuang, Hebei, China
Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Caiping Deng
Role: primary
Fang Xie, M.D
Role: primary
Xianqian Chen
Role: primary
Yisheng Lin
Role: primary
Zheng Zheng
Role: primary
Other Identifiers
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HINH2301
Identifier Type: -
Identifier Source: org_study_id
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