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Comparison of the Human Papillomavirus (HPV) Type 16 E7-Specific Immune Response Between a Normal Population and Patients With Cervical Lesions

This study is currently Recruiting

January 2003 By National Taiwan University Hospital

First Recieved on September 9, 2005

Last Updated on December 20, 2006

Sponsor: National Taiwan University Hospital
Collaborators:
Information provided by: National Taiwan University Hospital
Identifier: NCT00154583

Purpose

Cervical cancer is the most frequent neoplasm and the third in mortality rate of the malignancies in women in the world. It results in about 200,000 women dying of cervical cancer each year worldwide. The available forms of treatment - surgery, radiation therapy, and chemotherapy - are all cytoreductive treatment modalities, so, in addition to killing cancerous cells, healthy cells are also destroyed in the process. Indeed, there is a need to decrease the incidence of cervical cancer and develop better forms for its treatment. Human papillomaviruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16, 18, 31, 45) which have been strongly associated with cervical cancer. HPV 16 was found in more than 50% of cervical cancer tissues. So, the host immune response plays an important role in determining the regression of a cervical abnormality or persistence and progression to a malignancy via targeting HPV. The ideal cancer treatment should be able to eradicate systemic tumors at multiple sites in the body while having the specificity to discriminate between neoplastic and nonneoplastic cells. In this regard, antigen-specific cancer immunotherapy represents an attractive approach for cancer treatment. By cooperating with Dr. TC Wu at the Johns Hopkins Medical Institutes, the investigators have recently developed some E7-specific cancer vaccines of different strategies such as DNA, or replication-defective SINrep5 virus. They found that these E7-chimeric DNA vaccines are capable of preventing and treating the growth of murine model tumors expressing E7. These positive results from the preclinical murine models have encouraged the investigators to focus on the development of a cancer vaccine and immunotherapy and apply these vaccines to human subjects. However, it is very important to set up various E7-specific immunologic assays of human beings to evaluate the effects of a cancer vaccine or immunotherapy in future clinical trials. So the investigators would like to provide this proposal to address the development of HPV 16 E7-specific immunologic assays in human beings. There are two main goals in this study. First, the investigators would like to establish and compare the differences of HPV type 16 E7-specific immunologic responses between the normal population, people with HPV infection, patients with cervical intraepithelial neoplastic (CIN) lesions, and patients with cervical cancer. Second, they would like to correlate the disease severity of cervical cancer with the immunologic responses to HPV type 16 E7 antigen.

Study Type: Observational
Study Design: Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:Accepts Healthy Volunteers
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.

Investigators

  • Investigator: Chi-An Chen, MD - Principal Investigator - National Taiwan University Hospital

Locations

  • National Taiwan University Hospital

    Taipei, Taiwan

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