Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2007

Last Updated Date

August 12, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sensitivity and specificity of the HPV test of the material from the tampon self-test [ Time Frame: Spring 2008 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00526370 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Official Title ^ICMJE

Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Brief Summary

The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses.

Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.

Detailed Description

Study Phase

Phase 0

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Cross-Sectional

Condition ^ICMJE

Normal Uterine Cervical Cytology
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms

Intervention ^ICMJE

Study Arms / Comparison Groups

Women with at least moderate dysplasia in biopsies from cervix uteri
Women with only normal PAP-smears

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

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women with cervical dysplasia been referred to conisation.
Women invited to cervical screening program and with only normal smear and normal smears in their history.

Exclusion Criteria:

Women not performing the tampon self-test before conisation.
Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.

Gender

Female

Ages

23 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00526370

Responsible Party

Else Toft Würtz, Student

Study ID Numbers ^ICMJE

TP07-2351

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Hans Svanholm, Head of department

Region Hospital, Department of Pathology

Information Provided By

University of Aarhus

Verification Date

August 2008

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