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Trial Title:
Screening and Identification of Biomarkers on Cervical Cancers
NCT ID:
NCT00854269
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
surgery
Description:
cervical biopsy or specimen of hysterectomy
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 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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
25 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
WEN-FANG CHENG, ASSOCIATE PROFESSOR
Phone:
886-2-23123456
Email:
wenfangcheng@yahoo.com
Start date:
January 2007
Completion date:
January 2011
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00854269
