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

This study has been completed.

First Received: September 6, 2007 Last Updated: August 12, 2008 History of Changes

Sponsor:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00526370

Purpose

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.

Condition	Phase
Normal Uterine Cervical Cytology Uterine Cervical Dysplasia Uterine Cervical Neoplasms	Phase 0

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional
Official Title:	Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Tampon self-test from cervix

Enrollment:	72
Study Start Date:	August 2007
Study Completion Date:	July 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Women with at least moderate dysplasia in biopsies from cervix uteri
B Women with only normal PAP-smears

Eligibility

Ages Eligible for Study:	23 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

50 women in out-patient gynecological ward in account of cervical cell changes and 50 women in the national screening program for cervical cancer, included by their G.P.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526370

Locations

Denmark
Region Hospital Randers
Randers, Denmark, 8900

Sponsors and Collaborators

University of Aarhus

Investigators

Study Director:

Hans Svanholm, Head of department

Region Hospital, Department of Pathology

More Information

No publications provided

Responsible Party:	Student ( Else Toft Würtz )
Study ID Numbers:	TP07-2351
Study First Received:	September 6, 2007
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00526370 History of Changes
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by University of Aarhus:

self test
PAP smear
tampon test

E6/E7
mRNA
HPV

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Precancerous Conditions
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Carcinoma
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms

Genital Diseases, Female
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Carcinoma in Situ
Uterine Neoplasms
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009