Human Papilloma Virus DNA Self-Test

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00266266

Acronym

HPV

Enrollment

171

Registered

2005-12-16

Start date

2004-01-31

Completion date

2008-10-31

Last updated

2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papilloma Virus, Human

Keywords

Human Papilloma Virus

Brief 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?

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results