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The Development of Human Papillomavirus Type 16 E7-Specific Human Immunologic Assays in Non-HLA2 Type Human Being

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ClinicalTrials.gov Identifier: NCT00155792
Recruitment Status : Unknown
Verified December 2001 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 20, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:

Cervical cancer the most frequent neoplasm and the third mortality rate of malignancies of the 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 of its treatment.

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. 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 cervical abnormality or persistence and progression to 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 represent an attractive approach for cancer treatment. It is now clear that major histocompatibility complex (MHC) class I restricted CD8+ T cytotoxic cells are critical to the generation of antitumor immunity. Cell-mediated responses are critical in anti-tumor immunity.

By cooperating with Dr. TC Wu in Johns Hopkins Medical Institutes, we have recently developed some E7-specific cancer vaccines of different strategies such as DNA, or replication-defective SINrep5 virus. We 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 us to focus on the development of 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 being to evaluate the effect of cancer vaccine or immunotherapy in the future clinical trials. So we would like to provide this proposal to address on the development of HPV 16 E7-specific immunologic assays in human being.


Condition or disease
Cervical Cancer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Study Start Date : January 2002
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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

Inclusion Criteria:

normal volunteer, patients with CIN lesions or cervical cancers whose HLA haplotype is not HLA-A2


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 ClinicalTrials.gov identifier (NCT number): NCT00155792


Contacts
Contact: Wen-Fang Cheng, MD, PhD 886-2-2312-3456 ext 5166 wenfangcheng@yahoo.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Wen-Fang Cheng, MD, PhD    886-2-2312-3456 ext 5166    wenfangcheng@yahoo.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Fang Cheng, MD, PhD National Taiwan University Hospital

ClinicalTrials.gov Identifier: NCT00155792     History of Changes
Other Study ID Numbers: 9100208476
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 20, 2005
Last Verified: December 2001

Keywords provided by National Taiwan University Hospital:
ervical cancer, human papillomavirus, immunotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female