Prognostic Study of HPV Virus Integration in Women With HSIL

Prognostic Study of Different HPV Virus Integration in Women With HSIL

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. Based on clinical practice, the purpose of this study was to: 1) identify the correlation between HPV integration and the outcome of disease in HSIL women. 2) To determine the prognostic value of different HPV gene integration status in HSIL women. 3) To clarify the relationship between different HPV gene integration status and diversity of vaginal flora in HSIL women.

Study Overview

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

Detailed Description

A total of 1000 women with HSIL were recruited from multiple centers. In this prospective cohort study, 4 samples of cervical exfoliated cells and fornix secretions were collected at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal flora diversity sequencing, and 2 samples of peripheral blood (whole blood and serum) were collected at enrollment. The effects of HPV integration status and microbiota changes on the outcome and progression of HSIL were evaluated.

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

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Maternity and Child Health Hospital
    • Longyan, Fujian, China
      • Active, not recruiting
      • Longyan First Hospital
    • Longyan, Fujian, China
      • Active, not recruiting
      • Longyan People's Hospital
    • Nanping, Fujian, China
      • Recruiting
      • Nanping Second Hospital
      • Contact: Caiping Deng; Phone Number: 086-599-5621267
    • Ningde, Fujian, China
      • Recruiting
      • MinDong Hospital of Ningde City
      • Contact: Fang Xie, M.D
    • Ningde, Fujian, China
      • Active, not recruiting
      • Ningde City Hospital
    • Putian, Fujian, China
      • Active, not recruiting
      • Affiliated Hospital of Putian University
    • Putian, Fujian, China
      • Recruiting
      • Putian First Hospital
      • Contact: Xianqian Chen
    • Sanming, Fujian, China
      • Recruiting
      • Sanming Second Hospital
      • Contact: Yisheng Lin; Phone Number: 086-13507576151
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Maternity and Child Healthcare Hospital
      • Contact: Zheng Zheng
  • Hebei
    • Shijiazhuang, Hebei, China
      • Active, not recruiting
      • Shijiazhuang Obstetrics and Gynecology Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Active, not recruiting
      • Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Active, not recruiting
      • Maternal and Child Health Hospital of Hubei Province

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive carcinoma

Description

Inclusion Criteria:

• Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive cancer;
• No surgical treatment or conization only;
• Obtain informed consent.

Exclusion Criteria:

• During pregnancy or lactation;
• Patients with a history of genital tract cancer;
• Previous history of hysterectomy, cervical surgery or pelvic radiotherapy;
• Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month;
• Use of antibiotics or vaginal microecological improvement products in the past 1 month.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology; In this study, women with pathologically confirmed HSIL(CIN2, 3) or women with cervical carcinoma in situ or early invasive cancer will be included. All participants will have four follow-up visits at enrollment and at months 6, 12, and 24.	Other: Follow up; Four samples of cervical exfoliated cells and fornix secretions were collected from all subjects at enrollment, 6 months, 12 months and 24 months for HPV integration status and vaginal microbiota diversity sequencing, and two additional samples of peripheral blood (whole blood + serum) were collected at enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical cytology testing at baseline	All participants were tested for cervical cytology at the time of baseline.	Baseline
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 24-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 24-month follow-up.	24-month follow-up
16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	Baseline
Human Papillomavirus (HPV) viral integration test at baseline	Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.	Baseline
Human Papillomavirus (HPV) viral integration test at 6-month follow-up	Human Papillomavirus (HPV) viral integration test was performed at 6-month follow-up for all participants.	6-month follow-up
Human Papillomavirus (HPV) viral integration test at 12-month follow-up	Human Papillomavirus (HPV) viral integration test was performed at 12-month follow-up for all participants.	12-month follow-up
Cervical cytology testing at 12-month follow-up	All participants were tested for cervical cytology at 12-month follow-up	12-month follow-up
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
Cervical cytology testing at 6-month follow-up	All participants were tested for cervical cytology at 6-month follow-up for all participants.	6-month follow-up
Cervical cytology testing at 24-month follow-up	Cervical exfoliated cells and vaginal tissue samples were collected was performed at All participants were tested for cervical cytology at 24-month follow-up	24-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
Human Papillomavirus (HPV) viral integration test at 24-month follow-up	Human Papillomavirus (HPV) viral integration test was performed at 24-month follow-up for all participants.	24-month follow-up

Collaborators and Investigators

• Sponsor: Fujian Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: HINH2301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No