Evaluation of ELISA Assay on Human Papilloma Viruses (HPV) Infection Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673192
Recruitment Status : Unknown
Verified January 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 7, 2008
Last Update Posted : May 7, 2008
Information provided by:
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Patient With Invasive Cervical Carcinoma Patient With CIN Lesion Patient With HPV Infected Patients Without Histopathologic Lesion Normal Populations. Procedure: peripheral blood isolation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of ELISA Assay on HPV Infection Population
Study Start Date : January 2008
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : December 2008

Intervention Details:
  • Procedure: peripheral blood isolation
    to isolate serum from patient peripheral blood to test the titer of HPV infection and cytokine expression

Primary Outcome Measures :
  1. overall survival [ Time Frame: from disease diagnosis to death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673192

Contact: WEN-FANG CHENG, Associate Professor 886-2-23123456 ext 5166

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: WEN-FANG CHENG, ASSOCIATE PROFESSOR    886-2-23123456 ext 5166   
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: Chi-An Chen/Professor, National Taiwan University Hospital Identifier: NCT00673192     History of Changes
Other Study ID Numbers: 200710041R
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: January 2008