The Correlations Between HPV L1-Specific Immunologic Responses in Cervical Cancer and Cervical Intraepithelial Neoplasia (CIN) Patients and Their Prognosis

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Brief Title

The Correlations Between HPV L1-Specific Immunologic Responses in Cervical Cancer and Cervical Intraepithelial Neoplasia (CIN) Patients and Their Prognosis

Official Title

The Correlations Between HPV L1-Specific Immunologic Responses in Cervical Cancer and CIN Patients and Their Prognosis

Brief Summary

      A. To investigate the relationship between serum titer of anti-HPV16 antibody and
      clinicopathological factors of cervical cancer patients.

      B. To investigate that if the serum titer of anti-HPV16 antibody could be a prognostic factor
      in the cervical cancer patients.

      C. To investigate the serum titer of anti-HPV16 antibody in HPV16-infected populations with
      various disease status such as infection only, precancerous lesion, and early and advanced
      cervical cancer.
    

Detailed Description

      Cervical cancer is the most frequent neoplasm of the women in Taiwan and in the world.
      Cervical cancer affects half a million women each year and results in about 200,000 worldwide
      and it also influences about 2,700 women and about 1,000 women dying of cervical cancer each
      year and in Taiwan. There is strong evidence suggesting that this cancer is 100% attributable
      to infection with certain types of human papillomavirus (HPV); in fact, the World Health
      Organization (WHO) has very recently recognized that this cancer is caused by HPV. There are
      around 100 different HPV-types, of which around 40 types infecting the anogenital tract and
      causing cervical lesions and cervical cancer have been called High Risk HPV (i.e., HR-HPV-16,
      -18, -31, -33, and -58). From recent years, there is 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 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 other forms of malignancies, are
      at higher risk of developing CIN lesions and invasive cervical cancer. Moreover, several
      studies establish the existence of natural HPV-specific immunity in humans. Immune responses
      of the host are indeed critical in the virus-related infectious diseases. The immune response
      against HPV antigens is Human leukocyte antigen restricted. Consequently, the HLA class I and
      II phenotype may be correlated with an effective immune response against HPV associated
      cervical lesions. Differences in the recognition of foreign antigen, 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. Studies by different groups on associations between certain HLA
      alleles and susceptibility to, or protection against CIN lesions and cervical carcinoma,
      reveal varying conclusions and warrant further research.

      Most potentially oncogenic, persistent, long-term HPV infections induce an antibody response
      against virus proteins which can be detected by ELISA test and can be a good indicator of
      past as well as current infections and chronic active infection, associated with the presence
      of cervical lesions and the high risk of acquiring cervical cancer. In fact, it has been
      reported that women who are seropositive for HPV-16 present a higher risk of developing
      cervical carcinoma than seronegative women. L1-viral capsid proteins are one of the targets
      for antibodies induced by persistent HPV genital infection.

      The L1 protein represents more than 90% of the total protein on the surface of the virus.
      This protein is able to assemble itself, forming virus-like particles (VLPs). VLPs, mainly
      type 16, have been broadly used for studying the antibody response induced by genital
      HPVinfection. The VLP-antibody presence is stable in time, correlated with the number of
      sexual partners, and associated with persistent infection, viral load, and development of
      neoplasic lesions; this is rarely found in patients suffering from transitory infections.
      Seropositivity occurs more frequently in patients who have progressed to CIN III and invasive
      cancer than in those suffering from CIN I or CIN II and the antibody response is
      significantly higher in women having a higher viral load than those with lower viral load.
      Prospective studies have shown that 70-90% of HPV-16 infected women are seroconverted between
      6 and 18 months after HPV DNA has been detected and that this rarely occurs in patients
      detected as having transient HPV DNA.

      However, other serological studies have shown that 20-50% of women suffering from
      HPV-associated lesions, with HPV DNA presence, do not present detectable levels of anti-VLP
      antibodies; this is in part due to the lack of an optimized test and the fact that these
      antibodies reactivity is type-specific for the virus. An optimized VLP-based ELISA test has
      been recently reported showing 93% sensitivity and 98.5% specificity for discriminating
      between positive and negative control sera. However, there was no report to evaluate the
      antibody response in patients with HPV-infected cervical lesions and with the prognosis of
      these patients.

      So in the present proposal, we would like to examine the anti-L1 antibodies of various HPV
      types among Taiwanese women with HPV-related CIN or cervical cancer. The purposes of this
      proposal are 1) to address the immunologic responses to HPV between CIN and cervical cancer
      patients. , 2) to elucidate the correlation between immunologic responses to HPV and disease
      severity of cervical cancer., 3) to evaluate the correlation between immunologic responses to
      HPV and the prognosis of cervical cancer patients.

      The samples of patients' sera were collected on the day of surgery. 2. The sera samples were
      freezedon -200C until analyzed. 3. The sera samples will be shipped to the Lab. of Merck
      company in US. 4. HPV Serologic Assay A competitive radioimmunoassay developed by Merck
      Research Laboratories will be was used and perform to quantitate serum HPV- 6, 11, 16, 18,
      31, 33, 45, 51, 52, 58, 59, or 68 antibodies in Merck Research Laboratories (12). Results
      will be read from a standard curve, corrected for dilution, and reported in arbitrary units
      (milli-Merck Units, or mMU per milliliter). A fixed cutoff of 5.9 mMU per milliliter (derived
      by repeatedly testing a panel of positive and negative samples against the standard curve)
      will be used to determine the HPV-6, 11, 16, 18, 31, 33, 45, 51, 52, 58, 59, or 68 serologic
      status of the women.
    


Study Type

Interventional


Primary Outcome

overall survival


Condition

Cervical Cancer

Intervention

peripheral blood isolation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

600

Start Date

December 2005

Completion Date

December 2011

Primary Completion Date

January 2006

Eligibility Criteria

        Inclusion Criteria:

          1. cervical intrapeithelial neoplasm

          2. Cervical cancer

        Exclusion Criteria:
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Chi-An Chen, MD, 886-2-2312-3456, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT00728871

Organization ID

9461700838



Study Sponsor

National Taiwan University Hospital


Study Sponsor

Chi-An Chen, MD, Study Chair, National Taiwan University Hospital


Verification Date

August 2008