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

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283239
• Other study ID #: HIHP2201
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• HSIL, High-Grade Squamous Intraepithelial Lesions
• Infections
• LSIL, Low-Grade Squamous Intraepithelial Lesions
• Papillomavirus Infections
• Squamous Intraepithelial Lesions of the Cervix

Intervention

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.

Locations

Country	Name	City	State
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Longyan First Hospital	Longyan
China	Nanping Second Hospital	Nanjing
China	Mindong Hospital of Ningde City	Ningde	Fujian
China	Ningde Municipal Hospital of Ningde Normal University	Ningde	Fujian
China	The First Hospital of Putian City	Putian	Fujian
China	Quanzhou First Hospital Afflicated to Fujian Medical University	Quanzhou	Fujian
China	Sanming Second Hospital	Sanming
China	Shenzhen Maternity and child Healthcare Hospital	Shenzhen
China	Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	Zhangzhou affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian

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 histopathology testing at baseline	Cervical histopathology was performed at baseline for all participants.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Human Papillomavirus (HPV) virus integration test at baseline	Human Papillomavirus (HPV) virus integration test was performed at baseline for all participants.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
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 testing at the time of 6-month follow-up.	6-month follow-up
Primary	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
Primary	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
Primary	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
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 18-month follow-up	All participants underwent Human Papillomavirus (HPV) genotyping tests at 18-month follow-up.	18-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
Secondary	16SrRNA sequencing of the vaginal secretions at baseline	All participants underwent vaginal secretion sequencing at baseline.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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