Trial Title:
Prognostic Study of HPV Virus Integration in Women With HSIL
NCT ID:
NCT05745597
Condition:
HPV Infection
Virus Integration
HSIL, High Grade Squamous Intraepithelial Lesions
Conditions: Official terms:
Papillomavirus Infections
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Follow up
Description:
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.
Arm group label:
HSIL (CIN2,3) women or cervical carcinoma in situ or early invasive carcinoma confirmed by pathology
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.
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.
Criteria for eligibility:
Study pop:
Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early
invasive carcinoma
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Maternity and Child Health Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Binhua Dong
Phone:
+8613599071900
Email:
dbh18-jy@126.com
Facility:
Name:
Longyan First Hospital
Address:
City:
Longyan
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Longyan People's Hospital
Address:
City:
Longyan
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Nanping Second Hospital
Address:
City:
Nanping
Country:
China
Status:
Recruiting
Contact:
Last name:
Caiping Deng
Phone:
086-599-5621267
Facility:
Name:
Mindong Hospital of Ningde City
Address:
City:
Ningde
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang Xie, M.D
Facility:
Name:
Ningde City Hospital
Address:
City:
Ningde
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Affiliated Hospital of Putian University
Address:
City:
Putian
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Putian First Hospital
Address:
City:
Putian
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianqian Chen
Facility:
Name:
Sanming Second Hospital
Address:
City:
Sanming
Country:
China
Status:
Recruiting
Contact:
Last name:
Yisheng Lin
Phone:
086-13507576151
Facility:
Name:
Shenzhen Maternity and child Healthcare Hospital
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Zheng Zheng
Facility:
Name:
Shijiazhuang Obstetrics and Gynecology Hospital
Address:
City:
Shijiazhuang
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Maternal and Child Health Hospital of Hubei Province
Address:
City:
Wuhan
Country:
China
Status:
Active, not recruiting
Start date:
January 1, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Fujian Maternity and Child Health Hospital
Agency class:
Other
Source:
Fujian Maternity and Child Health Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745597
