A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL

NCT ID: NCT05282745

Last Updated: 2023-11-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-12-31

Brief Summary

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Human papillomavirus (HPV) infection has become one of the most important health problems faced by women all over the world. A large number of studies have shown that women's cervical, vaginal and perianal precancerous lesions, related cancers, condyloma acuminatum and other sexually transmitted diseases (STD) are closely related to HPV infection. Among them, the persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. Previous studies have shown that there are significant differences in the effects of multiple HPV infection and persistent infection of different types (such as type-16, -18, -39 and -52) on different levels of cervical lesions, and there is a certain correlation between HPV load in the process of persistent infection and the degree of cervical lesions. In addition, other studies have shown that HPV-16 viral load has certain clinical significance in predicting Cin2 / CIN3 high-grade cervical lesions, and HPV viral load level is significantly different in cervical low-grade squamous intraepithelial lesion (LSIL) and cervical high-grade squamous intraepithelial lesion (HSIL). The above biological changes such as HPV infection type, quantity and proportion can promote the occurrence and development of cervical precancerous lesions and related cancers to varying degrees. It can be seen that the study of the relationship between HPV viral load and cervical lesions is of great significance for clinical disease development prediction and cervical cancer screening.

Detailed Description

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Based on previous studies and clinical practice, this study carried out a multi center cohort study in China. In this study, ten research including Fujian Maternity and Child Health Hospital, Mindong Hospital of Ningde City, Zhangzhou affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Afflicated to Fujian Medical University, The First Hospital of Putian City, Ningde Municipal Hospital of Ningde Normal University, Shenzhen Maternity and child Healthcare Hospital and Maternity and child Hospital of Hubei Province were included, each of which included 400 individuals, with a total of 4000 women with high-grade squamous intraepithelial lesion were enrolled. For the first time, the investigators will collect 2 samples of cervical exfoliated cells and 4 samples of vaginal fornix swabs from participants, then at the 6th, 12th and 24th months after the first sampling, the participants need to return to the hospital, collected 2 samples of cervical exfoliated cells and 4 samples of vaginal fornix swabs again in order to observe and record the development of the disease. During this process, if abnormal cervical lesions are found, the participants will be biopsied under colposcopy according to relevant guidelines. Samples from cervix would be sent for PCR-sequencing, HPV tests and Thinprep cytologic test (TCT). And samples from vaginal fornix would be sent for sequencing and bioinformatic analysis. A prospective cohort study was conducted to explore the correlation between the characteristics, progression and prognosis of female genital tract lesions and HPV infection type, load and vaginal microenvironment.

Conditions

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HPV Infection HSIL, High-Grade Squamous Intraepithelial Lesions Viral Load

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with high-grade squamous intraepithelial lesion (HSIL) in cervix

In the enrollment, women whose cervical histopathological results have been diagnosed as high-grade squamous intraepithelial lesion (HSIL) for the last 3 months with abnormal results will be included in this study. All participants will be followed up three times, at 6 months,12 months and 24 months.

Follow-up

Intervention Type OTHER

Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.

Interventions

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Follow-up

Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women aged 20 and over.
* The result of cervical histopathology in the last 3 months was high-grade squamous intraepithelial lesion (HSIL).
* Non pregnant people with sexual history.
* Asexual life, no vaginal medication or flushing before 72 hours of sampling.

Exclusion Criteria

* Within 8 weeks after pregnancy or postpartum.
* 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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Maternity and Child Health Hospital

OTHER

Sponsor Role lead

Responsible Party

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Binhua Dong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pengming Sun, PhD

Role: STUDY_CHAIR

Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University

Locations

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Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Mindong Hospital of Ningde City

Ningde, Fujian, China

Site Status RECRUITING

Ningde Municipal Hospital of Ningde Normal University

Ningde, Fujian, China

Site Status RECRUITING

The First Hospital of Putian City

Putian, Fujian, China

Site Status RECRUITING

Quanzhou First Hospital Afflicated to Fujian Medical University

Quanzhou, Fujian, China

Site Status RECRUITING

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

Site Status RECRUITING

Longyan First Hospital

Longyan, , China

Site Status RECRUITING

Shenzhen Maternity and child Healthcare Hospital

Shenzhen, , China

Site Status RECRUITING

Maternity and child Hospital of Hubei Province

Wuhan, , China

Site Status RECRUITING

Xiamen Maternity and Child Health Hospital

Xiamen, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Binhua Dong

Role: CONTACT

+86-591-87558732

Facility Contacts

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Binhua Dong

Role: primary

+86-591-87558732

Fang Xie, M.D

Role: primary

Wenfang Jin

Role: primary

Xianqian Chen

Role: primary

Yuchun' Lv, M.D

Role: primary

Feifeng Shi, M.D

Role: primary

Jinyong Wang

Role: primary

Zheng Zheng

Role: primary

Hongning Cai

Role: primary

Qing Li

Role: primary

Other Identifiers

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PVLHCF

Identifier Type: -

Identifier Source: org_study_id

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