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HPV Viral Load in Predicting the Prognosis of LSIL

A Multicenter Cohort Study of HPV Viral Load in Predicting the Prognosis of Women With LSIL in Cervix

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05051852
Enrollment
1000
Registered
2021-09-21
Start date
2021-09-01
Completion date
2024-12-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection, LSIL, Low-Grade Squamous Intraepithelial Lesions, Viral Load

Brief summary

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

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.

Interventions

OTHERFollow 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.

Sponsors

Fujian Maternity and Child Health Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Tests for vaginal microbiota at baseline at 24-month follow-up24-month follow-upAll participants underwent tests for vaginal microbiota at the time of 24-month follow-up.
Sequencing of the vaginal secretions at 12-month follow-up12-month follow-upAll participants underwent vaginal secretion sequencing at the time of 12-month follow-up.
Sequencing of the vaginal secretions at 24-month follow-up24-month follow-upAll participants underwent vaginal secretion sequencing at the time of 24-month follow-up.
Tests for vaginal microbiota at baseline at 6-month follow-up6-month follow-upAll participants underwent tests for vaginal microbiota at the time of 6-month follow-up.
Tests for vaginal microbiota at baseline at 12-month follow-up12-month follow-upAll participants underwent tests for vaginal microbiota at the time of 12-month follow-up.
Tests for vaginal microbiota at baselineBaselineAll participants underwent tests for vaginal microbiota at baseline.
Cervical histopathology testing at baselineBaselineCervical histopathology was performed at baseline for all participants.
Cervical histopathology testing at 6-month follow-up6-month follow-upCervical histopathology was performed at 6-month follow-up for cervical HPV infection or cytology abnormalities women.
Cervical histopathology testing at 12-month follow-up12-month follow-upCervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.
Cervical histopathology testing at 24-month follow-up24-month follow-upCervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.
Human Papillomavirus (HPV) viral load test at baselineBaselineHuman Papillomavirus (HPV) viral load test was performed at baseline for all participants.
Human Papillomavirus (HPV) viral load test at 6-month follow-up6-month follow-upAll participants were tested for HPV viral load at the time of 6-month follow-up.
Human Papillomavirus (HPV) viral load test at 12-month follow-up12-month follow-upAll participants were tested for HPV viral load at the time of 12-month follow-up.
Human Papillomavirus (HPV) viral load test at 24-month follow-up24-month follow-upAll participants were tested for HPV viral load at the time of 24-month follow-up.
Cervical cytology testing at baselineBaselineAll participants were tested for cervical cytology at the time of baseline.
Cervical cytology testing at 6-month follow-up6-month follow-upAll participants were tested for Cervical cytology testing at the time of 6-month follow-up.
Cervical cytology testing at 12-month follow-up12-month follow-upAll participants were tested for Cervical cytology testing at the time of 12-month follow-up.
Cervical cytology testing at 24-month follow-up24-month follow-upAll participants were tested for Cervical cytology testing at the time of 24-month follow-up.
Sequencing of the vaginal secretions at baselineBaselineAll participants underwent vaginal secretion sequencing at baseline.
Sequencing of the vaginal secretions at 6-month follow-up6-month follow-upAll participants underwent vaginal secretion sequencing at the time of 6-month follow-up.

Secondary

MeasureTime frameDescription
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up6-month follow-upAll participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 6-month follow-up.
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up12-month follow-upAll participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 12-month follow-up.
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up24-month follow-upAll participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 24-month follow-up.
Human Papillomavirus (HPV) genotyping tests at baselineBaselineAll participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.

Countries

China

Contacts

Primary ContactBinhua Dong
dbh18-jy@126.com+8613599071900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026