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Evaluation of ELISA Assay on Human Papilloma Viruses (HPV) Infection Population
This study is currently recruiting participants.
Study NCT00673192   Information provided by National Taiwan University Hospital
First Received: May 5, 2008   Last Updated: May 6, 2008   History of Changes

May 5, 2008
May 6, 2008
January 2008
January 2008   (final data collection date for primary outcome measure)
overall survival [ Time Frame: from disease diagnosis to death ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00673192 on ClinicalTrials.gov Archive Site
 
 
 
Evaluation of ELISA Assay on Human Papilloma Viruses (HPV) Infection Population
Evaluation of ELISA Assay on HPV Infection Population

Cervical cancer the most frequent neoplasm and the fifth mortality rate of malignancies of the women in the world. It results in about 1,000 women in Taiwan and about 200,000 women worldwide dying of cervical cancer each year. Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16,18,31,45) have been strongly associated with cervical cancer. Around 50-80 % of women are infected by HPV within their whole lives. However, only 1% of HPV-infected women have cervical cancer eventually. Seventy and 91% of HPV infection could be cleaned up by host immune responses within 1 and 2 years later. It shows that host immunity plays an important role in the progression, persistence, or regression of HPV infection.

There are two main defense lines in the host immunity including innate immunity and adoptive immunity. Adoptive immunity plays more important roles in the defense of HPV infections than innate immunity. The adoptive immunity could be further divided into humoral immunity and cell-mediated immunity. Humoral immunity regulated by Th2 helper T lymphocytes to generate memory B cells to produce antibody which provide the protective function to HPV infection. Cell-mediated immunity regulated by Th1 helper T lymphocytes to induce antigen-specific cytotoxic T cells which could kill the HPV-infected cells. Although there are many researches focused on the immunity to HPV infection, there is no conclusion about the relationship between humoral and cell-mediated immunities on HPV infection and roles of humoral and cell-mediated immunities in the prognosis of HPV-infected population and cervical cancer patients.

Our research team has focused on the establishment of platforms on cell-mediated immunity to HPV infection and on the correlation of cell-mediated immunity and prognosis of HPV-infected population and cervical cancer patients for years. In order to survey the host immunity to HPV infection more comprehensively, we propose this proposal. First, we would like to set up the platforms to elucidate the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to survey the correlation betweem humoral immunity and status and clinico-pathologic items of HPV-infected populations. Our research results will have a more comprehensive overview in the host immunity to HPV infection and its related diseases. It could provide more information in the prevention and treatment of HPV infection in the future.

 
 
Interventional
Basic Science, Open Label, Placebo Control, Single Group Assignment
  • Patient With Invasive Cervical Carcinoma
  • Patient With CIN Lesion
  • Patient With HPV Infected Patients Without Histopathologic Lesion
  • Normal Populations.
Procedure: peripheral blood isolation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
December 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
25 Years to 55 Years
Yes
Contact: WEN-FANG CHENG, Associate Professor 886-2-23123456 ext 5166 wenfangcheng@yahoo.com
Taiwan
 
NCT00673192
Chi-An Chen/Professor, National Taiwan University Hospital
200710041R
National Taiwan University Hospital
 
 
National Taiwan University Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP