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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00526370
Other study ID # TP07-2351
Secondary ID
Status Completed
Phase Phase 0
First received September 6, 2007
Last updated August 12, 2008
Start date August 2007
Est. completion date July 2008

Study information

Verified date August 2008
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 23 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Locations

Country Name City State
Denmark Region Hospital Randers Randers

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of the HPV test of the material from the tampon self-test Spring 2008 No
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