Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

This study has been completed.

First Received on September 18, 2006. Last Updated on March 26, 2008 History of Changes

Sponsor:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00377845

Purpose

The purpose of this study is to compare suitability, specificity and sensitivity of the routine smear and the tampon self-test women perform at home.

Study hypothesis: The tampon self-test correspond to the routine cervical smear.

Condition	Intervention	Phase
Uterine Cervical Dysplasia Uterine Cervical Neoplasms	Procedure: Regular Tampax used in 3 hours	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Screening
Official Title:	Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.

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 tampon self-test

Secondary Outcome Measures:

The womens socio-demographic relations according to accept the tampon self-test

Estimated Enrollment:	100
Study Start Date:	September 2006
Study Completion Date:	March 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	23 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women with cervical dysplasia been referred to conisation or
Women invited to cervical screening program

Exclusion Criteria:

Women not performing the tampon self-test before conisation or
Women not performing the tampon self-test af least 1 month after receiving the tampon

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377845

Locations

Denmark
Region Hospital Randers
Randers, Denmark, 8900

Sponsors and Collaborators

University of Aarhus

Investigators

Study Director:

Hans Svanholm, consultant

Randers Hospital, Pathological Institute

More Information

No publications provided

Responsible Party:	Else Toft Würtz, Student
ClinicalTrials.gov Identifier:	NCT00377845 History of Changes
Other Study ID Numbers:	TP06-2351
Study First Received:	September 18, 2006
Last Updated:	March 26, 2008
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by University of Aarhus:

self test
PAP smear
tampon test
cervical dysplasia

Additional relevant MeSH terms:

Neoplasms
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2012