Brief Title
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
Official Title
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
Brief 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.
Study Type
Observational
Primary Outcome
Sensitivity and specificity of the HPV test of the material from the tampon self-test
Condition
Normal Uterine Cervical Cytology
Study Arms / Comparison Groups
A
Description: Women with at least moderate dysplasia in biopsies from cervix uteri
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
72
Start Date
August 2007
Completion Date
July 2008
Primary Completion Date
February 2008
Eligibility Criteria
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.
Gender
Female
Ages
23 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Hans Svanholm, Head of department, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00526370
Organization ID
TP07-2351
Study Sponsor
University of Aarhus
Study Sponsor
Hans Svanholm, Head of department, Study Director, Region Hospital, Department of Pathology
Verification Date
August 2008