Viewing Study NCT00154479



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Study NCT ID: NCT00154479
Status: UNKNOWN
Last Update Posted: 2006-12-14
First Post: 2005-09-09

Brief Title: The Correlation Between the Haplotype of Human Leukocyte Antigen HLA and Human Papillomavirus
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2003-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Cervical cancer is the most frequent neoplasm of women in Taiwan and in the world It influences about 2700 women with about 1000 women dying of cervical cancer each year and in Taiwan Human papillomaviruses HPV have been consistently implicated in causing cervical cancer especially those high-risk types which have been strongly associated with cervical cancer In recent years there has been compelling evidence that infection with human papillomavirus HPV is a major etiologic factor in the development of cervical intraepithelial neoplasia CIN and cervical carcinoma

As in most virus-induced diseases an adequate immune response is likely to play a key role in the clearance of HPV infections and HPV-related lesions This assumption is born out by both epidemiological studies and animal models Immune-compromised patients such as HIV-infected women organ transplant recipients and patients suffering from other forms of malignancies are at a higher risk of developing CIN lesions and invasive cervical cancer Moreover several studies establish the existence of natural HPV E7-specific cytotoxic T lymphocyte CTL immunity in humans Only a minority of women infected with oncogenic HPV types develop CIN or cervical cancer Indeed the majority of CIN lesions do not progress or even regress to normal cytology indicating that other factors such as an inadequate immune function are necessary for the development of progressive CIN lesions and cervical carcinoma

Consequently the HLA class I and II phenotypes may be correlated with an effective immune response against HPV-associated cervical lesions Differences in the recognition of foreign antigens such as those contributed by alleles at the HLA class I or II loci might be proposed to affect the risk of developing cervical cancer

In the present proposal the investigators would like to examine the HLA class I and II associations among Taiwanese women with cervical neoplasia The purposes of this proposal are

1 to address the relationships between the HLA class I and II haplotype HPV infection and cervical cancer and
2 to elucidate the immunologic responses to HPV type 16 in different HLA class I and II haplotypes It will help the investigators to identify which population of HLA genotypes is more susceptible to HPV infection and progresses to invasive cervical cancer The results of this research will be very useful for the prevention and screening of cervical cancer in the future
Detailed Description: 1 To survey the incidence of HPV infection in CIN and cervical cancer patients

Using epidemiologic data drawn from a wide range of countries and population groups investigators have found evidence of HPV in 90 to 95 of cervical cancers The incidence of HPV in cervical cancer was 79 in our own report Besides 91 of high-grade CIN cases and 50 of low-grade CIN cases could be attributed to HPV infection in Taiwanese women Because these reports for Taiwanese women were published around 10 years ago it is important to survey and update the incidence of HPV in CIN and cervical cancer patients in Taiwanese women We will survey the incidence of HPV infection in 500 cervical cancer patients 100 patients of CIN and 100 normal population patients
2 To survey the human leukocyte antigen haplotype in CIN and cervical cancer patients

HLA class I and II alleles have been reported to associate with the nasopharyngeal carcinoma in Taiwan Besides human leukocyte antigen class I and II alleles might interplay in the response to interferon-alpha treatment in Taiwanese patients with chronic hepatitis C virus infection We will detect the HLA class I and II haplotype first and then correlate them with the CIN and cervical cancer patients
3 To identify the correlation between HLA class I and II haplotype and HPV infection and CIN and cervical cancer

We will further survey the correlation between HLA class I and II and the genotypes of HPV in CIN and cervical cancer patients We will identify which HLA class I and II haplotypes have positive or negative correlation with HPV infection CIN and cervical cancer Then we would determine which specific HLA antigens are important in determining the risk of HPV infection CIN and cervical cancer
4 To elucidate the immunologic responses to HPV type 16 in HLA2 with different II haplotypes and the role of immunogenetics in the carcinogenesis of cervical cancer

HPV type 16 has been identified to be the highest incidence of malignant HPV genotypes in cervical cancer Our laboratory has set up immunologic assays for evaluating the immune responses to HPV type 16 We will survey the immune response to HPV type 16 in those HLA class I and II haplotypes which have positive or negative correlation with the HPV infection and cervical cancer We would identify which population of HLA genotype are more susceptible to HPV infection and invasive cervical cancer and elucidate the role of immunogenetics in the HPV infection and carcinogenesis of cervical cancer

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None