Back to resultsCervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Primary Purpose
Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Regular Tampax used in 3 hours
Sponsored by
About this trial
This is an interventional screening trial for Uterine Cervical Dysplasia focused on measuring self test, PAP smear, tampon test, cervical dysplasia
Eligibility 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
Sites / Locations
- Region Hospital Randers
Outcomes
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
Full Information
NCT ID
NCT00377845
First Posted
September 18, 2006
Last Updated
March 26, 2008
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00377845
Brief Title
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Official Title
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
Keywords
self test, PAP smear, tampon test, cervical dysplasia
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Regular Tampax used in 3 hours
Primary Outcome Measure Information:
Title
Sensitivity and specificity of the tampon self-test
Secondary Outcome Measure Information:
Title
The womens socio-demographic relations according to accept the tampon self-test
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Svanholm, consultant
Organizational Affiliation
Randers Hospital, Pathological Institute
Official's Role
Study Director
Facility Information:
Facility Name
Region Hospital Randers
City
Randers
ZIP/Postal Code
8900
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
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