Trial Information

A Multi-Center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-Up of LSIL Cases

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.