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Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions
This study is ongoing, but not recruiting participants.
First Received: March 30, 2009   No Changes Posted
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00872937
  Purpose

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.


Condition
Cervical Cancer

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Retrospective
Official Title: Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: from disease diagnosis to death ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 800
Study Start Date: March 2009
Estimated Study Completion Date: December 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

cervical cancer patients with HPVinfection

Criteria

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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872937

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital ( Wen-Fang Cheng/Associated Professor )
Study ID Numbers: 200812138R
Study First Received: March 30, 2009
Last Updated: March 30, 2009
ClinicalTrials.gov Identifier: NCT00872937     History of Changes
Health Authority: Taiwan: Department of Health

ClinicalTrials.gov processed this record on May 07, 2009