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

NCT00201370 | Completed DMC

• 1 other identifier: T1899
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief Summary

The aims of this study are:

1. 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. 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.

Conditions

Cervical Cancer; Low-grade Squamous Intraepithelial Lesion,; Human Papillomavirus

Keywords

cervical neoplasia;; human papillomavirus,; PCR,; risk factors,; Taiwan

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the disease-free survival.

  5

Secondary Outcomes (1)

• Secondary endpoints include overall survival and tumor response rate.

  5

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women were invited to participate in the cross-sectional study

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (4)

Kaohsiung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

Tri-Services General Hospital

Taipei, 11490, Taiwan

Location

National Taiwan University Hospital

Taipei, 115, Taiwan

Location

Chang-Gung Memorial Hospital(Lin-Kou),

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Journal of Medical Virology Volume 77, Issue 2, pages 273-281, October 2005

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Tang-Yuan Chu, M.D., Ph.D.

  Taiwan cooperative oncology group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 1999
• Primary Completion: February 1, 2004
• Study Completion: March 1, 2004
• Last Updated: March 25, 2016

Record last verified: 2005-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)