Uterine Cervical Neoplasms Clinical Trial
Official title:
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
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.
| 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. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Region Hospital Randers | Randers |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus |
Denmark,
| 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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