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

Completed

• Conditions: Normal Uterine Cervical Cytology; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

• Registration Number: NCT00526370
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-06
• Study First Posted: 2007-09-10
• Primary Completion: 2008-02
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-12
• Last Update Posted: 2008-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the HPV test of the material from the tampon self-test	Spring 2008

Trial Locations

Locations (1)

Region Hospital Randers; 🇩🇰 Randers, Denmark