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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Maternity and Child Health Hospital
RECRUITING
Fuzhou
Longyan First Hospital
RECRUITING
Longyan
Nanping Second Hospital
RECRUITING
Nanjing
Mindong Hospital of Ningde City
RECRUITING
Ningde
Ningde Municipal Hospital of Ningde Normal University
RECRUITING
Ningde
The First Hospital of Putian City
RECRUITING
Putian
Quanzhou First Hospital Afflicated to Fujian Medical University
RECRUITING
Quanzhou
Sanming Second Hospital
RECRUITING
Sanming
Shenzhen Maternity and child Healthcare Hospital
RECRUITING
Shenzhen
Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University
RECRUITING
Xiamen
Zhangzhou affiliated Hospital of Fujian Medical University
RECRUITING
Zhangzhou
Contact Information
Primary
Binhua Dong
dbh18-jy@126.com
+86-591-87558732
Backup
Pengming Sun, Study Chair
sunfemy@hotmail.com
+86-591-87558732
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 1000
Treatments
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.
Sponsors
Leads: Fujian Maternity and Child Health Hospital

This content was sourced from clinicaltrials.gov