Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

NCT00526370CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

72

Start Date

2007-08-01

Completion Date

2008-02-01

Study Type

OBSERVATIONAL

Official Title

Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Conditions

Normal Uterine Cervical CytologyUterine Cervical DysplasiaUterine Cervical Neoplasms

Eligibility

Age Range

23 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Sensitivity and specificity of the HPV test of the material from the tampon self-test

Time frame: Spring 2008

Locations

Region Hospital Randers, Randers, Denmark

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.