Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05051852
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-09-12
Brief Title:
HPV Viral Load in Predicting the Prognosis of LSIL
Sponsor:
Fujian Maternity and Child Health Hospital
Organization:
Fujian Maternity and Child Health Hospital
Study Overview
Official Title:
A Multicenter Cohort Study of HPV Viral Load in Predicting the Prognosis of Women With LSIL in Cervix
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Human papillomavirus HPV infection has become one of the most important health problems faced by women all over the world A large number of studies have shown that womens cervical vaginal and perianal precancerous lesions related cancers condyloma acuminatum and other sexually transmitted diseases STD are closely related to HPV infection Among them the persistent infection of high-risk human papillomavirus HR-HPV is closely related to the occurrence of invasive cervical cancer Previous studies have shown that there are significant differences in the effects of multiple HPV infection and persistent infection of different types such as type-16 -18 -39 and -52 on different levels of cervical lesions and there is a certain correlation between HPV load in the process of persistent infection and the degree of cervical lesions In addition other studies have shown that HPV-16 viral load has certain clinical significance in predicting Cin2 CIN3 high-grade cervical lesions and HPV viral load level is significantly different in cervical low-grade squamous intraepithelial lesion LSIL and cervical high-grade squamous intraepithelial lesion HSIL The above biological changes such as HPV infection type quantity and proportion can promote the occurrence and development of cervical precancerous lesions and related cancers to varying degrees It can be seen that the study of the relationship between HPV viral load and cervical lesions is of great significance for clinical disease development prediction and cervical cancer screening
Detailed Description:
Based on our previous studies and clinical practice this study carried out a multi center cohort study in Fujian Province China In this study six research including Fujian Maternity and Child Health Hospital Mindong Hospital of Ningde City Zhangzhou affiliated Hospital of Fujian Medical University Quanzhou First Hospital Afflicated to Fujian Medical University Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University and Ningde Municipal Hospital of Ningde Normal University were included each of which included 500 individuals with a total of 3000 women with low-grade squamous intraepithelial lesion were enrolled For the first time the researchers will collect 2 samples of cervical exfoliated cells one of which will be sub packed into 3 and 4 samples of vaginal fornix swabs from subjects then at the 6th 12th and 24th months after the first sampling the subjects need to return to the hospital collect 2 samples of cervical exfoliated cells one of which will be sub packed and 4 samples of vaginal fornix swabs again in order to observe and record the development of the disease During this process if abnormal cervical lesions are found the subjects will be biopsied under colposcopy according to relevant guidelines Samples from cervix would be sent for PCR-sequencing HPV tests and Thinprep cytologic test TCT And samples from vaginal fornix would be sent for sequencing and bioinformatic analysis A prospective cohort study was conducted to explore the correlation between the characteristics progression and prognosis of female genital tract lesions and HPV infection type load and vaginal microenvironment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None