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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2003 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154583
First received: September 9, 2005
Last updated: December 20, 2006
Last verified: January 2003
  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.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 500
Study Start Date: January 2003
Estimated Study Completion Date: December 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154583

Contacts
Contact: Chi-An Chen, MD 882-2-2312-3456 ext 5157 cachen@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chi-An Chen, MD    886-2-2312-3456 ext 5157    cachen@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chi-An Chen, MD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154583     History of Changes
Other Study ID Numbers: 9261701445
Study First Received: September 9, 2005
Last Updated: December 20, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cervical cancer
human papillomavirus
cancer vaccine
normal volunteer

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

ClinicalTrials.gov processed this record on September 18, 2014