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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154583
Recruitment Status : Unknown
Verified January 2003 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 21, 2006
Information provided by:
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease
Cervical Cancer

  Show Detailed Description

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Study Type : Observational
Enrollment : 500 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Study Start Date : January 2003
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154583

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Contact: Chi-An Chen, MD 882-2-2312-3456 ext 5157

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National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chi-An Chen, MD    886-2-2312-3456 ext 5157   
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Chi-An Chen, MD National Taiwan University Hospital

Layout table for additonal information Identifier: NCT00154583     History of Changes
Other Study ID Numbers: 9261701445
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 21, 2006
Last Verified: January 2003
Keywords provided by National Taiwan University Hospital:
cervical cancer
human papillomavirus
cancer vaccine
normal volunteer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female