Clinical trial NCT05283239: Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection
Official title: Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
LSIL, Low-Grade Squamous Intraepithelial Lesions
HSIL, High-Grade Squamous Intraepithelial Lesions
Virus Integration
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese women with persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +.

Brief summary: Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.

Detailed description: This study aims to: 1) determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection. 2) determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection. 3) determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection, and its prognostic value in women with LSIL and HSIL.

Eligibility criteria: Inclusion Criteria:

* Non pregnant people with sexual history；
* Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
* No history of previous surgery at the cervical site.
* 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 18-month follow-up
timeFrame: 18-month follow-up
measure: Cervical histopathology testing at 24-month follow-up
timeFrame: 24-month follow-up
measure: Human Papillomavirus (HPV) virus integration test at baseline
timeFrame: Baseline
measure: Human Papillomavirus (HPV) virus integration test at 6-month follow-up
timeFrame: 6-month follow-up
measure: Human Papillomavirus (HPV) virus integration test at 12-month follow-up
timeFrame: 12-month follow-up
measure: Human Papillomavirus (HPV) virus integration test at 18-month follow-up
timeFrame: 18-month follow-up
measure: Human Papillomavirus (HPV) virus integration 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 18-month follow-up
timeFrame: 18-month follow-up
measure: Cervical cytology testing at 24-month follow-up
timeFrame: 24-month follow-up
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 18-month follow-up
timeFrame: 18-month follow-up
measure: Human Papillomavirus (HPV) genotyping tests at 24-month follow-up
timeFrame: 24-month follow-up
Secondary outcomes:
measure: 16SrRNA sequencing of the vaginal secretions at baseline
timeFrame: Baseline
measure: 16SrRNA sequencing of the vaginal secretions at 6-month follow-up
timeFrame: 6-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 12-month follow-up
timeFrame: 12-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions at 18-month follow-up
timeFrame: 18-month follow-up
measure: 16SrRNA sequencing of the vaginal secretions 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: Ningde
country: China
facility: Ningde Municipal Hospital of Ningde Normal University
state: Fujian
city: Putian
country: China
facility: The First Hospital of Putian 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: Longyan
country: China
facility: Longyan First Hospital
city: Nanjing
country: China
facility: Nanping Second Hospital
city: Sanming
country: China
facility: Sanming Second Hospital
city: Shenzhen
country: China
facility: Shenzhen Maternity and child Healthcare Hospital
Study officials:
affiliation: Fujian Maternity and Child Health Hospital
name: Binhua Dong, MD
role: STUDY_CHAIR
References: