Human Papilloma Virus DNA Self-Test

Papilloma Virus, Human Clinical Trial

— HPV  

Official title:

Human Papilloma Virus DNA Self-Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266266
• Other study ID #: 529.03
• Status: Completed
• Phase: N/A
• First received: December 15, 2005
• Last updated: December 27, 2017
• Start date: January 2004
• Est. completion date: October 2008

Study information

• Verified date: December 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papilloma
• Papilloma Virus, Human

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV DNA self-testing device to detect disease in patients with abnormal Pap smear	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.	Patient will self-test immediately prior to their standard physician papsmear