Clinical trial NCT05051852: HPV Viral Load in Predicting the Prognosis of LSIL
Official title: A Multicenter Cohort Study of HPV Viral Load in Predicting the Prognosis of Women With LSIL in Cervix
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
LSIL, Low-Grade Squamous Intraepithelial Lesions
Viral Load
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese women aged 20 and over with low-grade squamous intraepithelial lesion in results of cervical histopathology.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical histopathology testing at baseline
timeFrame: Baseline
measure: Cervical histopathology testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: Cervical histopathology testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: Cervical histopathology testing at 24-month follow-up
timeFrame: 24-month follow-up
measure: Human Papillomavirus (HPV) viral load test at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) viral load test at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) viral load test at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) viral load test at 24-month follow-up
timeFrame: 24-month follow-up
measure: Cervical cytology testing at baseline
timeFrame: Baseline
measure: Cervical cytology testing at 6-month follow-up
timeFrame: 6-month follow-up
measure: Cervical cytology testing at 12-month follow-up
timeFrame: 12-month follow-up
measure: Cervical cytology testing at 24-month follow-up
timeFrame: 24-month follow-up
measure: Sequencing of the vaginal secretions at baseline
timeFrame: Baseline
measure: Sequencing of the vaginal secretions at 6-month follow-up
timeFrame: 6-month follow-up
measure: Sequencing of the vaginal secretions at 12-month follow-up
timeFrame: 12-month follow-up
measure: Sequencing of the vaginal secretions at 24-month follow-up
timeFrame: 24-month follow-up
measure: Tests for vaginal microbiota at baseline
timeFrame: Baseline
measure: Tests for vaginal microbiota at baseline at 6-month follow-up
timeFrame: 6-month follow-up
measure: Tests for vaginal microbiota at baseline at 12-month follow-up
timeFrame: 12-month follow-up
measure: Tests for vaginal microbiota at baseline at 24-month follow-up
timeFrame: 24-month follow-up
Secondary outcomes:
measure: Human Papillomavirus (HPV) genotyping tests at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) genotyping tests at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
timeFrame: 24-month follow-up
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Ningde
country: China
facility: Mindong Hospital of Ningde City
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital Afflicated to Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou affiliated Hospital of Fujian Medical University
state: Fujian
city: Foshan
country: China
facility: Shunde Women's and Children's Hospital of Guangdong Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Maternal and Child Health Hospital of Shenzhen Province
state: Guangdong
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
name: Pengming Sun, PhD
role: STUDY_CHAIR
References: