HPV Viral Load in Predicting the Prognosis of LSIL

NCT ID: NCT05051852

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

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 our previous studies and clinical practice, this study carried out a multi center cohort study in Fujian Province, China. In this study, six 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, Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University and Ningde Municipal Hospital of Ningde Normal University were included, each of which included 500 individuals, with a total of 3000 women with low-grade squamous intraepithelial lesion were enrolled. For the first time, the researchers will collect 2 samples of cervical exfoliated cells (one of which will be sub packed into 3) and 4 samples of vaginal fornix swabs from subjects, then at the 6th, 12th and 24th months after the first sampling, the subjects need to return to the hospital, collect 2 samples of cervical exfoliated cells (one of which will be sub packed) 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 subjects 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 LSIL, Low-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 low-grade squamous intraepithelial lesion (LSIL) in cervix

In the enrollment, women whose cervical histopathological results have been diagnosed as low-grade squamous intraepithelial lesion (LSIL) 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 low-grade squamous intraepithelial lesion (LSIL).
* 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

Quanzhou First Hospital Afflicated to Fujian Medical University

Quanzhou, Fujian, China

Site Status RECRUITING

Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

Site Status RECRUITING

Shunde Women's and Children's Hospital of Guangdong Medical University

Foshan, Guangdong, China

Site Status RECRUITING

Maternal and Child Health Hospital of Shenzhen Province

Shenzhen, Guangdong, China

Site Status RECRUITING

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Binhua Dong

Role: CONTACT

+8613599071900

Facility Contacts

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Binhua Dong

Role: primary

+8613599071900

Fang Xie, M.D

Role: primary

+8613860388999

Yuchun' Lv, M.D

Role: primary

+8618965652996

Qing Li, M.D

Role: primary

+8613328755276

Feifeng Shi, M.D

Role: primary

+8613960086066

Shaomei Lin

Role: primary

+8618027686151

Zheng Zheng, M.D

Role: primary

+8613500056539

Hongning Cai, M.D

Role: primary

+8615926224867

Other Identifiers

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PVLLCF

Identifier Type: -

Identifier Source: org_study_id

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