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

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282745
• Other study ID #: PVLHCF
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Fujian Maternity and Child Health Hospital
• Contact: Binhua Dong
• Phone: +86-591-87558732
• Email: dbh18-jy[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HPV Infection
• HSIL, High-Grade Squamous Intraepithelial Lesions
• Papillomavirus Infections
• Recurrence
• Viral Load

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Longyan First Hospital	Longyan
China	Mindong Hospital of Ningde City	Ningde	Fujian
China	Ningde Municipal Hospital of Ningde Normal University	Ningde	Fujian
China	The First Hospital of Putian City	Putian	Fujian
China	Quanzhou First Hospital Afflicated to Fujian Medical University	Quanzhou	Fujian
China	Shenzhen Maternity and child Healthcare Hospital	Shenzhen
China	Maternity and child Hospital of Hubei Province	Wuhan
China	Xiamen Maternity and Child Health Hospital	Xiamen
China	Zhangzhou affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical histopathology testing at baseline	Cervical histopathology was performed at baseline for all participants.	Baseline
Primary	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.	6-month follow-up
Primary	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.	12-month follow-up
Primary	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.	24-month follow-up
Primary	Human Papillomavirus (HPV) viral load test at baseline	Human Papillomavirus (HPV) viral load test was performed at baseline for all participants.	Baseline
Primary	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.	6-month follow-up
Primary	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.	12-month follow-up
Primary	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.	24-month follow-up
Primary	Cervical cytology testing at baseline	All participants were tested for cervical cytology at the time of baseline.	Baseline
Primary	Cervical cytology testing at 6-month follow-up	All participants were tested for Cervical cytology testing at the time of 6-month follow-up.	6-month follow-up
Primary	Cervical cytology testing at 12-month follow-up	All participants were tested for Cervical cytology testing at the time of 12-month follow-up.	12-month follow-up
Primary	Cervical cytology testing at 24-month follow-up	All participants were tested for Cervical cytology testing at the time of 24-month follow-up.	24-month follow-up
Primary	16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	Baseline
Primary	16SrRNA sequencing the vaginal secretions at 6-month follow-up	All participants underwent vaginal secretion sequencing at the time of 6-month follow-up.	6-month follow-up
Primary	16SrRNA sequencing of the vaginal secretions at 12-month follow-up	All participants underwent vaginal secretion sequencing at the time of 12-month follow-up.	12-month follow-up
Primary	16SrRNA sequencing of the vaginal secretions at 24-month follow-up	All participants underwent vaginal secretion sequencing at the time of 24-month follow-up.	24-month follow-up
Secondary	Human Papillomavirus (HPV) genotyping tests at baseline	All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.	Baseline
Secondary	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.	6-month follow-up
Secondary	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.	12-month follow-up
Secondary	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.	24-month follow-up