Prognostic Study of HPV Virus Integration in Women With HSIL

NCT05745597 | Unknown DMC

• 1 other identifier: HINH2301
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

HPV Infection; Virus Integration; HSIL, High Grade Squamous Intraepithelial Lesions

Outcome Measures

Primary Outcomes (16)

• 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 at 6-month follow-up for all participants.

  6-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

• 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 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 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 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

• 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

• 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

Study Arms (1)

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

Interventions

Follow up OTHER

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.

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (13)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Longyan First Hospital

Longyan, Fujian, China

ACTIVE NOT RECRUITING

Longyan People's Hospital

Longyan, Fujian, China

ACTIVE NOT RECRUITING

Nanping Second Hospital

Nanping, Fujian, China

RECRUITING

Mindong Hospital of Ningde City

Ningde, Fujian, China

RECRUITING

Ningde City Hospital

Ningde, Fujian, China

ACTIVE NOT RECRUITING

Affiliated Hospital of Putian University

Putian, Fujian, China

ACTIVE NOT RECRUITING

Putian First Hospital

Putian, Fujian, China

RECRUITING

Sanming Second Hospital

Sanming, Fujian, China

RECRUITING

Shenzhen Maternity and child Healthcare Hospital

Shenzhen, Guangdong, China

RECRUITING

Shijiazhuang Obstetrics and Gynecology Hospital

Shijiazhuang, Hebei, 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

Wuhan, Hubei, China

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples from the cervix and vagina containing relevant cells, tissues and secretions, as well as peripheral blood samples.

MeSH Terms

Conditions

Papillomavirus Infections; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Study Officials

• Pengming Sun

  Fujian Maternal and Child Health Hospital

  STUDY CHAIR

Central Study Contacts

Binhua Dong

CONTACT

+86-591-87558732; dbh18-jy@126.com

Pengming Sun

CONTACT

+86-591-87558732; sunfemy@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: January 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

CN (13)