Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
NCT ID: NCT05283239
Last Updated: 2023-11-18
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
2022-01-01
2024-12-31
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 with persistent HR-HPV infection
In the enrollment, women with persistent HR-HPV infection for more than 18 months will be included in this study. All participants will be followed up at 6th month, 12th month, 18th month and 24th month after baseline of recruitment.
Follow up
Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.
Interventions
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Follow up
Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.
Eligibility Criteria
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Inclusion Criteria
* Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
* No history of previous surgery at the cervical site.
* Asexual life, no vaginal medication or flushing before 72 hours of sampling.
Exclusion Criteria
* Patients with history of genital tract tumor.
* History of HPV vaccination.
* Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
* In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
* Use antibiotics or vaginal microecological improvement products in recent 1 month.
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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Binhua Dong, MD
Role: STUDY_CHAIR
Fujian Maternity and Child Health Hospital
Locations
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Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
Mindong Hospital of Ningde City
Ningde, Fujian, China
Ningde Municipal Hospital of Ningde Normal University
Ningde, Fujian, China
The First Hospital of Putian City
Putian, Fujian, China
Quanzhou First Hospital Afflicated to Fujian Medical University
Quanzhou, Fujian, China
Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
Zhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
Longyan First Hospital
Longyan, , China
Nanping Second Hospital
Nanjing, , China
Sanming Second Hospital
Sanming, , China
Shenzhen Maternity and child Healthcare Hospital
Shenzhen, , China
Countries
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Central Contacts
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Facility Contacts
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Fang Xie, M.D
Role: primary
Wenfang Jin
Role: primary
Xianqian Chen
Role: primary
Yuchun' Lv, M.D
Role: primary
Qing Li, M.D
Role: primary
Feifeng Shi, M.D
Role: primary
Jinyong Wang
Role: primary
Caiping Deng
Role: primary
Yisheng Lin
Role: primary
Zheng Zheng
Role: primary
Other Identifiers
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HIHP2201
Identifier Type: -
Identifier Source: org_study_id
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