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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00526370

Enrollment

Registered

2007-09-10

Start date

2007-08-31

Completion date

2008-07-31

Last updated

2008-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Uterine Cervical Cytology, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms

Keywords

self test, PAP smear, tampon test, E6/E7, mRNA, HPV

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

23 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of the HPV test of the material from the tampon self-test	Spring 2008

Countries

Denmark

Outcome results