- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377845
Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear.
March 26, 2008 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Randers, Denmark, 8900
- Region Hospital Randers
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Sensitivity and specificity of the tampon self-test
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Secondary Outcome Measures
Outcome Measure |
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The womens socio-demographic relations according to accept the tampon self-test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hans Svanholm, consultant, Randers Hospital, Pathological Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
September 18, 2006
First Submitted That Met QC Criteria
September 18, 2006
First Posted (Estimate)
September 19, 2006
Study Record Updates
Last Update Posted (Estimate)
March 27, 2008
Last Update Submitted That Met QC Criteria
March 26, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Uterine Cervical Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
Other Study ID Numbers
- TP06-2351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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