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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201370
First received: September 14, 2005
Last updated: March 23, 2016
Last verified: September 2005

September 14, 2005
March 23, 2016
August 1999
February 2004   (final data collection date for primary outcome measure)
The primary endpoint is the disease-free survival. [ Time Frame: 5 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00201370 on ClinicalTrials.gov Archive Site
Secondary endpoints include overall survival and tumor response rate. [ Time Frame: 5 ] [ Designated as safety issue: No ]
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A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases
A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample
Women were invited to participate in the cross-sectional study
  • Cervical Cancer
  • Low-grade Squamous Intraepithelial Lesion,
  • Human Papillomavirus
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Sun CA, Hsiung CA, Lai CH, Chen CA, Chou CY, Ho CM, Twu NF, Feng WL, Chuang MH, Hsieh CY, Chu TY. Epidemiologic correlates of cervical human papillomavirus prevalence in women with abnormal Pap smear tests: a Taiwan Cooperative Oncology Group (TCOG) study. J Med Virol. 2005 Oct;77(2):273-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2004
February 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women visiting the gynecologic clinic of the participating medical centers and have a recent (within three months) Pap smear result of ASCUS, AGCUS, LSIL and HSIL of during the study period will be invited to this study.
  • An informed consent signed.

Exclusion Criteria:

- Women who are not pregnant, had had no previous CIN

Female
20 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00201370
T1899
Yes
No
Not Provided
National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
Not Provided
Principal Investigator: Tang-Yuan Chu, M.D., Ph.D. Taiwan cooperative oncology group
National Health Research Institutes, Taiwan
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP