HPV Viral Load in Predicting the Prognosis of LSIL

Fujian Maternity and Child Health Hospital1,000 enrolled

Overview

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.

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

Sex: FEMALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, China

RECRUITING

Mindong Hospital of Ningde City

Ningde, Fujian, China

RECRUITING

Quanzhou First Hospital Afflicated to Fujian Medical University

Quanzhou, Fujian, China

RECRUITING

Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

RECRUITING

Zhangzhou affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

RECRUITING

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

Foshan, Guangdong, China

RECRUITING

Maternal and Child Health Hospital of Shenzhen Province

Shenzhen, Guangdong, China

RECRUITING

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Cervical histopathology testing at baseline

Cervical histopathology was performed at baseline for all participants.

Time frame: Baseline

Cervical histopathology testing at 6-month follow-up

Cervical histopathology was performed at 6-month follow-up for cervical HPV infection or cytology abnormalities women.

Time frame: 6-month follow-up

Cervical histopathology testing at 12-month follow-up

Cervical histopathology was performed at 12-month follow-up for cervical HPV infection or cytology abnormalities women.

Time frame: 12-month follow-up

Cervical histopathology testing at 24-month follow-up

Cervical histopathology was performed at 24-month follow-up for cervical HPV infection or cytology abnormalities women.

Time frame: 24-month follow-up

Human Papillomavirus (HPV) viral load test at baseline

Human Papillomavirus (HPV) viral load test was performed at baseline for all participants.

Time frame: Baseline

Human Papillomavirus (HPV) viral load test at 6-month follow-up

All participants were tested for HPV viral load at the time of 6-month follow-up.

Time frame: 6-month follow-up

Human Papillomavirus (HPV) viral load test at 12-month follow-up

All participants were tested for HPV viral load at the time of 12-month follow-up.

Time frame: 12-month follow-up

Human Papillomavirus (HPV) viral load test at 24-month follow-up

All participants were tested for HPV viral load at the time of 24-month follow-up.

Time frame: 24-month follow-up

Cervical cytology testing at baseline

All participants were tested for cervical cytology at the time of baseline.

Time frame: Baseline

Cervical cytology testing at 6-month follow-up

All participants were tested for Cervical cytology testing at the time of 6-month follow-up.

Time frame: 6-month follow-up

Cervical cytology testing at 12-month follow-up

All participants were tested for Cervical cytology testing at the time of 12-month follow-up.

Time frame: 12-month follow-up

Cervical cytology testing at 24-month follow-up

All participants were tested for Cervical cytology testing at the time of 24-month follow-up.

Time frame: 24-month follow-up

Sequencing of the vaginal secretions at baseline

All participants underwent vaginal secretion sequencing at baseline.

Time frame: Baseline

Sequencing of the vaginal secretions at 6-month follow-up

All participants underwent vaginal secretion sequencing at the time of 6-month follow-up.

Time frame: 6-month follow-up

Sequencing of the vaginal secretions at 12-month follow-up

All participants underwent vaginal secretion sequencing at the time of 12-month follow-up.

Time frame: 12-month follow-up

Sequencing of the vaginal secretions at 24-month follow-up

All participants underwent vaginal secretion sequencing at the time of 24-month follow-up.

Time frame: 24-month follow-up

Tests for vaginal microbiota at baseline

All participants underwent tests for vaginal microbiota at baseline.

Time frame: Baseline

Tests for vaginal microbiota at baseline at 6-month follow-up

All participants underwent tests for vaginal microbiota at the time of 6-month follow-up.

Time frame: 6-month follow-up

Tests for vaginal microbiota at baseline at 12-month follow-up

All participants underwent tests for vaginal microbiota at the time of 12-month follow-up.

Time frame: 12-month follow-up

Tests for vaginal microbiota at baseline at 24-month follow-up

All participants underwent tests for vaginal microbiota at the time of 24-month follow-up.

Time frame: 24-month follow-up

Secondary Outcomes

Human Papillomavirus (HPV) genotyping tests at baseline

All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.

Time frame: Baseline

Human Papillomavirus (HPV) genotyping tests at 6-month follow-up

All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 6-month follow-up.

Time frame: 6-month follow-up

Human Papillomavirus (HPV) genotyping tests at 12-month follow-up

All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 12-month follow-up.

Time frame: 12-month follow-up

Human Papillomavirus (HPV) genotyping tests at 24-month follow-up

All participants underwent Human Papillomavirus (HPV) genotyping tests at the time of 24-month follow-up.

Time frame: 24-month follow-up

HPV Viral Load in Predicting the Prognosis of LSIL

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts