Human Papilloma Virus DNA Self-Test - Tabular View

Tracking Information

First Received Date ^ICMJE

December 15, 2005

Last Updated Date

May 21, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00266266 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Human Papilloma Virus DNA Self-Test

Official Title ^ICMJE

Human Papilloma Virus DNA Self-Test

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other

Condition ^ICMJE

Papilloma Virus, Human

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

October 2008

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00266266

Responsible Party

Lynn P. Parker, MD, James Graham Brown Cancer Center

Study ID Numbers ^ICMJE

529.03

Study Sponsor ^ICMJE

James Graham Brown Cancer Center

Collaborators ^ICMJE

University of Louisville

Investigators ^ICMJE

Principal Investigator:

Robert Edwards, MD

University of Louisville,James Graham Brown Cancer Center

Information Provided By

James Graham Brown Cancer Center

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP