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

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ClinicalTrials.gov Identifier: NCT00377845
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
University of Aarhus

Brief Summary:

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 or disease Intervention/treatment Phase
Uterine Cervical Dysplasia Uterine Cervical Neoplasms Procedure: Regular Tampax used in 3 hours Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Screening
Official Title: Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2008

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Primary Outcome Measures :
  1. Sensitivity and specificity of the tampon self-test

Secondary Outcome Measures :
  1. The womens socio-demographic relations according to accept the tampon self-test


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Ages Eligible for Study:   23 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Else Toft Würtz, Student
ClinicalTrials.gov Identifier: NCT00377845     History of Changes
Other Study ID Numbers: TP06-2351
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Keywords provided by University of Aarhus:
self test
PAP smear
tampon test
cervical dysplasia

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site