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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201370
• Other study ID #: T1899
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: March 23, 2016
• Start date: August 1999
• Est. completion date: March 2004

Study information

• Verified date: September 2005
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Human Papillomavirus
• Low-grade Squamous Intraepithelial Lesion,
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Services General Hospital	Taipei
Taiwan	Chang-Gung Memorial Hospital(Lin-Kou),	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the disease-free survival.		5	No
Secondary	Secondary endpoints include overall survival and tumor response rate.		5	No

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