Prognostic Study of HPV Virus Integration in Women With HSIL

HPV Infection Clinical Trial

Official title:

Prognostic Study of Different HPV Virus Integration in Women With HSIL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745597
• Other study ID #: HINH2301
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: February 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• HPV Infection
• HSIL, High Grade Squamous Intraepithelial Lesions
• Papillomavirus Infections

Intervention

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.

Locations

Country	Name	City	State
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Longyan First Hospital	Longyan	Fujian
China	Longyan People's Hospital	Longyan	Fujian
China	Nanping Second Hospital	Nanping	Fujian
China	Mindong Hospital of Ningde City	Ningde	Fujian
China	Ningde City Hospital	Ningde	Fujian
China	Affiliated Hospital of Putian University	Putian	Fujian
China	Putian First Hospital	Putian	Fujian
China	Sanming Second Hospital	Sanming	Fujian
China	Shenzhen Maternity and child Healthcare Hospital	Shenzhen	Guangdong
China	Shijiazhuang Obstetrics and Gynecology Hospital	Shijiazhuang	Hebei
China	Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei

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 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 at 6-month follow-up for all participants.	6-month follow-up
Primary	Cervical cytology testing at 12-month follow-up	All participants were tested for cervical cytology at 12-month follow-up	12-month follow-up
Primary	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
Primary	16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	Baseline
Primary	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
Primary	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
Primary	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
Primary	Human Papillomavirus (HPV) viral integration test at baseline	Human Papillomavirus (HPV) viral integration test was performed at baseline for all participants.	Baseline
Primary	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
Primary	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
Primary	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
Primary	Human Papillomavirus (HPV) genotyping tests at baseline	All participants underwent Human Papillomavirus (HPV) genotyping tests at baseline.	Baseline
Primary	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
Primary	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
Primary	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