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Human Papilloma Virus DNA Self-Test (HPV)

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: James Graham Brown Cancer Center
University of Louisville
Information provided by: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00266266
  Purpose

HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?


Condition
Papilloma Virus, Human

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other
Official Title:   Human Papilloma Virus DNA Self-Test

Further study details as provided by James Graham Brown Cancer Center:

Estimated Enrollment:   200
Study Start Date:   January 2004
Estimated Study Completion Date:   October 2008
Primary Completion Date:   September 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Abnormal pap smear ASCUS or higher

Age 18-postmenopausal

Exclusion Criteria:

Less than 18 years old

Prior hysterectomy

Pregnancy

Use of corticosteroids

HIV positive

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266266

Locations
United States, Kentucky
James Graham Brown Cancer Center    
      Louisville, Kentucky, United States, 40202

Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville

Investigators
Principal Investigator:     Robert Edwards, MD     University of Louisville,James Graham Brown Cancer Center    
  More Information

Responsible Party:   James Graham Brown Cancer Center ( Lynn P. Parker, MD )
Study ID Numbers:   529.03
First Received:   December 15, 2005
Last Updated:   May 21, 2008
ClinicalTrials.gov Identifier:   NCT00266266
Health Authority:   United States: Food and Drug Administration

Keywords provided by James Graham Brown Cancer Center:
Human Papilloma Virus  

Study placed in the following topic categories:
Virus Diseases
Neoplasms, Squamous Cell
Papilloma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 05, 2008




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