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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201370
First Posted: September 20, 2005
Last Update Posted: March 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multi-center Survey of HPV in Cervical Intraepithelial Neoplasia (CIN) With Longitudinal Follow-up of LSIL Cases

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary endpoint is the disease-free survival. [ Time Frame: 5 ]

Secondary Outcome Measures:
  • Secondary endpoints include overall survival and tumor response rate. [ Time Frame: 5 ]

Enrollment: 1000
Study Start Date: August 1999
Study Completion Date: March 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women were invited to participate in the cross-sectional study
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201370


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

Additional Information:
Publications:
Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00201370     History of Changes
Other Study ID Numbers: T1899
First Submitted: September 14, 2005
First Posted: September 20, 2005
Last Update Posted: March 25, 2016
Last Verified: September 2005
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Squamous Intraepithelial Lesions of the Cervix
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Cervical Dysplasia
Precancerous Conditions