Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection

Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China

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.

Study Overview

• Status: Recruiting
• Conditions: HPV Infection; LSIL, Low-Grade Squamous Intraepithelial Lesions; HSIL, High-Grade Squamous Intraepithelial Lesions; Virus Integration
• Intervention / Treatment: Other: Follow up

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Pengming Sun, Study Chair; Phone Number: +86-591-87558732; Email: sunfemy@hotmail.com
• Study Contact Backup: Name: Binhua Dong; Phone Number: +86-591-87558732; Email: dbh18-jy@126.com

Study Locations

• China
  • Longyan, China
    • Recruiting
    • Longyan First Hospital
    • Contact: Jinyong Wang
  • Nanjing, China
    • Recruiting
    • Nanping Second Hospital
    • Contact: Caiping Deng
  • Sanming, China
    • Recruiting
    • Sanming Second Hospital
    • Contact: Yisheng Lin
  • Shenzhen, China
    • Recruiting
    • Shenzhen Maternity and Child Healthcare Hospital
    • Contact: Zheng Zheng
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Maternity and Child Health Hospital
      • Contact: Binhua Dong; Phone Number: +86-591-87558732; Email: dbh18-jy@126.com
    • Ningde, Fujian, China, 352000
      • Recruiting
      • MinDong Hospital of Ningde City
      • Contact: Fang Xie, M.D
    • Ningde, Fujian, China, 352100
      • Recruiting
      • Ningde Municipal Hospital of Ningde Normal University
      • Contact: Wenfang Jin
    • Putian, Fujian, China, 351100
      • Recruiting
      • The First Hospital of Putian City
      • Contact: Xianqian Chen
    • Quanzhou, Fujian, China, 362000
      • Recruiting
      • Quanzhou First Hospital Afflicated to Fujian Medical University
      • Contact: Yuchun' Lv, M.D
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
      • Contact: Qing Li, M.D
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Zhangzhou Affiliated Hospital of Fujian Medical University
      • Contact: Feifeng Shi, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 +.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with persistent HR-HPV infection; In the enrollment, women with persistent HR-HPV infection for more than 18 months will be included in this study. All participants will be followed up at 6th month, 12th month, 18th month and 24th month after baseline of recruitment.	Other: Follow up; Participants will be followed up at 6th，12th, 18th and 24th months with HPV viral integration/genotyping tests, thinprep cytologic tests (TCT) for cervix and vaginal secretion tests. Colposcopy and biopsy will be conducted for participants if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical histopathology testing at baseline	Cervical histopathology was performed at baseline for all participants.	Baseline
Cervical histopathology testing at 6-month follow-up	Cervical histopathology was performed at 6-month follow-up for cervical HR-HPV infection or cytology abnormalities women	6-month follow-up
Cervical histopathology testing at 12-month follow-up	Cervical histopathology was performed at 12-month follow-up for cervical HR-HPV infection or cytology abnormalities women	12-month follow-up
Cervical histopathology testing at 18-month follow-up	Cervical histopathology was performed at 18-month follow-up for cervical HR-HPV infection or cytology abnormalities women	18-month follow-up
Cervical histopathology testing at 24-month follow-up	Cervical histopathology was performed at 24-month follow-up for cervical HR-HPV infection or cytology abnormalities women	24-month follow-up
Human Papillomavirus (HPV) virus integration test at baseline	Human Papillomavirus (HPV) virus integration test was performed at baseline for all participants.	Baseline
Human Papillomavirus (HPV) virus integration test at 6-month follow-up	Human Papillomavirus (HPV) virus integration test was performed at 6-month follow-up for all participants.	6-month follow-up
Human Papillomavirus (HPV) virus integration test at 12-month follow-up	Human Papillomavirus (HPV) virus integration test was performed at 12-month follow-up for all participants.	12-month follow-up
Human Papillomavirus (HPV) virus integration test at 18-month follow-up	Human Papillomavirus (HPV) virus integration test was performed at 18-month follow-up for all participants.	18-month follow-up
Human Papillomavirus (HPV) virus integration test at 24-month follow-up	Human Papillomavirus (HPV) virus integration test was performed at 24-month follow-up for all participants.	24-month follow-up
Cervical cytology testing at baseline	All participants were tested for cervical cytology at the time of baseline.	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.	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.	12-month follow-up
Cervical cytology testing at 18-month follow-up	All participants were tested for Cervical cytology testing at the time of 18-month follow-up.	18-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.	24-month follow-up
Human Papillomavirus (HPV) genotyping tests at baseline	All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.	Baseline
Human Papillomavirus (HPV) genotyping tests at 6-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 6-month follow-up.	6-month follow-up
Human Papillomavirus (HPV) genotyping tests at 12-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 12-month follow-up.	12-month follow-up
Human Papillomavirus (HPV) genotyping tests at 18-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 18-month follow-up.	18-month follow-up
Human Papillomavirus (HPV) genotyping tests at 24-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.	24-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	Baseline
16SrRNA sequencing of the vaginal secretions at 6-month follow-up	All participants underwent vaginal secretion sequencing at 6-month follow-up.	6-month follow-up
16SrRNA sequencing of the vaginal secretions at 12-month follow-up	All participants underwent vaginal secretion sequencing at 12-month follow-up.	12-month follow-up
16SrRNA sequencing of the vaginal secretions at 18-month follow-up	All participants underwent vaginal secretion sequencing at 18-month follow-up.	18-month follow-up
16SrRNA sequencing of the vaginal secretions at 24-month follow-up	All participants underwent vaginal secretion sequencing at 24-month follow-up.	24-month follow-up

Collaborators and Investigators

• Sponsor: Fujian Maternity and Child Health Hospital
• Investigators: Study Chair: Binhua Dong, MD, Fujian Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Precancerous Conditions; Uterine Cervical Dysplasia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infections; Communicable Diseases; Papillomavirus Infections; Squamous Intraepithelial Lesions of the Cervix
• Other Study ID Numbers: HIHP2201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No