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A Multi-Center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-Up of LSIL Cases
This study has been completed.
First Received: September 14, 2005   No Changes Posted
Sponsors and Collaborators: National Health Research Institutes, Taiwan
National Taiwan University Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
Cathay General Hospital
Taipei Veterans General Hospital,Taiwan
Information provided by: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00201370
  Purpose

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.

Condition
Cervical Cancer
Low-Grade Squamous Intraepithelial Lesion,
Human Papillomavirus

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: A Multi-Center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-Up of LSIL Cases

Further study details as provided by National Health Research Institutes, Taiwan:

Estimated Enrollment: 1000
Study Start Date: August 1999
Estimated Study Completion Date: November 2005
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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201370

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 115
Chang-Gung Memorial Hospital(Lin-Kou),
Taoyuan, Taiwan, 333
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 80708
Veterans General Hospital-Taipei
Taipei, Taiwan, 112
Tri-Services General Hospital
Taipei, Taiwan, 11490
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
Cathay General Hospital
Taipei Veterans General Hospital,Taiwan
Investigators
Principal Investigator: Tang-Yuan Chu, M.D., Ph.D. Taiwan cooperative oncology group
  More Information

Additional Information:
No publications provided

Study ID Numbers: T1899
Study First Received: September 14, 2005
Last Updated: September 14, 2005
ClinicalTrials.gov Identifier: NCT00201370     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
cervical neoplasia;
human papillomavirus,
PCR,
risk factors,
Taiwan

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Diseases
Precancerous Conditions
Carcinoma in Situ
Uterine Diseases
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Genital Diseases, Female
Uterine Cervical Diseases
Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Carcinoma in Situ
Uterine Diseases
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on May 07, 2009