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Screening and Identification of Biomarkers on Cervical Cancers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00854269
First received: April 1, 2008
Last updated: March 22, 2009
Last verified: March 2009
  Purpose

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 3-year proposal. First, we would like to set up the platforms to survey the humoral immunity to HPV infection in normal population and patients with CIN lesion or cervical cancer. Second, we would to elucidate the correlation between humoral immunity and status and clinico-pathologic items of HPV-infected populations. Third, we would like to survey if the humoral immunity correlate with the prognosis of patients with cervical lesions. Fourth, we would like to elucidate the correlation betweenHLA haplotype and humoral immunity in 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 Intervention
Cervical Cancer
Procedure: surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Screening and Identification of Novel Diagnostic and Prognosis Biomarkers on Cervical Cancers

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: 250
Study Start Date: January 2007
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: surgery
    cervical biopsy or specimen of hysterectomy
  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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: NCT00854269

Contacts
Contact: WEN-FANG CHENG, Associate Professor 886-2-23123456 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: WEN-FANG CHENG, ASSOCIATE PROFESSOR    886-2-23123456    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Chi-An Chen/Professor, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00854269     History of Changes
Other Study ID Numbers: 200705075R
Study First Received: April 1, 2008
Last Updated: March 22, 2009
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on November 25, 2014