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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00872937
First received: March 30, 2009
Last updated: May 16, 2012
Last verified: March 2012
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions

Resource links provided by NLM:


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 ]

Estimated Enrollment: 800
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872937

Contacts
Contact: Wen-Fang Cheng, Associated Professor 886-2-23123456 ext 65175 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: wen-Fang Cheng, Associated Professor    886-2-23123456 ext 65175    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Fang Cheng National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00872937     History of Changes
Other Study ID Numbers: 200812138R
Study First Received: March 30, 2009
Last Updated: May 16, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014