Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions

Cervical Cancer Clinical Trial

Official title:

Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00872937
• Other study ID #: 200812138R
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2009
• Last updated: May 16, 2012
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: National Taiwan University Hospital
• Contact: Wen-Fang Cheng, Associated Professor
• Phone: 886-2-23123456
• Email: wenfangcheng[@]yahoo.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Human papillomavirus (HPV) infection plays a key role in the carcinogenesis of cervical cancer and pre-invasive lesions. There are hundred types of HPV, including high risk and low risk types, and it is proved the close association between the cervical cancer and high risk HPV. While HPV 16 and 18 are known to be the leading two genotypes detected in women with cervical neoplasm worldwide, there is considerable difference in the other prevalent high risk genotypes in different geographic areas. It is important to establish the local database about the cervical intraepithelial lesions and the related prevalent HPV genotypes. The investigators designed a retrospective study which included total 784 patients managed at our hospital from January 1, 2000 to December 31, 2007. The present study was to investigate the HPV genotypes in the Taiwanese female patients with abnormal cervical cytology and analyses the association between HPV types and cervical pre-invasive lesions. It could provide the guide for the clinicians in the management of patients with abnormal cytological change of Pap smear.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• People infected with HPV type 16 but without CIN lesions

• Patients with CIN lesions

• Patients with cervical cancer from National Taiwan University Hospital

• Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards.

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		from disease diagnosis to death	No