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Human Papilloma Virus DNA Self-Test


N/A
18 Years
N/A
Not Enrolling
Female
Papilloma Virus, Human

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Trial Information

Human Papilloma Virus DNA Self-Test


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

HPV DNA self-testing device to detect disease in patients with abnormal Pap smear

Outcome Description:

To assess the concordance of HPV DNA self-testing device to detect disease in patients with abnormal Pap smear. Patients with a positive HPV Self-test by vaginal swab or vaginal tampon will be compared to the physician test results for concordance. Following patient self-sample collection, physician will collect cervical samples using a spatula. A self testing device which patients can use at their convenience will be beneficial in decreasing the incidence of cervical cancer in Kentucky.

Outcome Time Frame:

Patient will self-test immediately prior to their standard physician papsmear

Safety Issue:

No

Principal Investigator

Robert Edwards, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville,James Graham Brown Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

529.03

NCT ID:

NCT00266266

Start Date:

January 2004

Completion Date:

October 2008

Related Keywords:

  • Papilloma Virus, Human
  • Human Papilloma Virus
  • Papilloma
  • Virus Diseases

Name

Location
James Graham Brown Cancer Center Louisville, Kentucky  40202