Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201370
Status:
COMPLETED
Last Update Posted:
2016-03-25
First Post:
2005-09-14
Brief Title:
A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia CIN With Longitudinal Follow-up of LSIL Cases
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia CIN With Longitudinal Follow-up of LSIL Cases
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The aims of this study are
1 Surveillance of the prevalence of HPV infection in ASCUS AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors
2 Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases
1 Surveillance of the prevalence of HPV infection in ASCUS AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors
2 Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases
Detailed Description:
Carcinoma of the uterine cervix is by far the most prevalent cancer of women in Taiwan and worldwide In 1994 it ranked the top of female cancer incidence with 3000 new cases annually and claimed nearly 1000 lives The major cause of this malignant disease is now pointed to the infection of oncogenic types of human papillomavirus HPV HPV infection is sexually transmitted affects the immature metaplastic cells of uterine cervix and in an unknown proportion results in squamous intraepithelial lesion SIL of differing severity The natural history of HPV infection is by far elusive It is not clear how the virus get into the cell how the immune system respond to it and how the epithelial cell get transformed An average estimation holds that about 60 of low grade SIL will regress 30 will persist 10 will progress to high grade lesions and less than 1 become invasive lesions
The aims of this study are
1 Surveillance of the prevalence of HPV infection in ASCUS AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors
2 Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases
Through a consensus of management of patients with abnormal Pap smear in TGOG a standard protocol of specimen collection clinical follow-up has been established Patients with a Pap smear of ASCUS AGCUS or SIL will be arranged with a repeat Pap smear and a colposcopy with or without biopsy A cervical swab will be taken and sent to the core laboratory for HPV DNA detection and genotyping Pap smear and biopsies were then panel-reviewed by Pathologists Cytology-or pathology-proved LSIL cases will be followed every three months with Pap smear colposcopy and HPV test until disease progression or two consecutive negative results of all the three data One thousand cases fulfilling aim 1 will be analyzed during the first year and the nature course of about 300 LSIL cases will be followed at the end of the third year
The aims of this study are
1 Surveillance of the prevalence of HPV infection in ASCUS AGCUS and SIL cases pooled from medical centers in Taiwan and analysis of the related epidemiological factors
2 Providing a better understanding of the natural history of HPV infection with its correlation with pathologic changes through a longitudinal follow-up of LSIL cases
Through a consensus of management of patients with abnormal Pap smear in TGOG a standard protocol of specimen collection clinical follow-up has been established Patients with a Pap smear of ASCUS AGCUS or SIL will be arranged with a repeat Pap smear and a colposcopy with or without biopsy A cervical swab will be taken and sent to the core laboratory for HPV DNA detection and genotyping Pap smear and biopsies were then panel-reviewed by Pathologists Cytology-or pathology-proved LSIL cases will be followed every three months with Pap smear colposcopy and HPV test until disease progression or two consecutive negative results of all the three data One thousand cases fulfilling aim 1 will be analyzed during the first year and the nature course of about 300 LSIL cases will be followed at the end of the third year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None