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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526370
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : August 13, 2008
Information provided by:
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.

Condition or disease
Normal Uterine Cervical Cytology Uterine Cervical Dysplasia Uterine Cervical Neoplasms

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
Study Start Date : August 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Women with at least moderate dysplasia in biopsies from cervix uteri
Women with only normal PAP-smears

Primary Outcome Measures :
  1. Sensitivity and specificity of the HPV test of the material from the tampon self-test [ Time Frame: Spring 2008 ]

Biospecimen Retention:   Samples With DNA
Tampon self-test from cervix

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Ages Eligible for Study:   23 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
50 women in out-patient gynecological ward in account of cervical cell changes and 50 women in the national screening program for cervical cancer, included by their G.P.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526370

Region Hospital Randers
Randers, Denmark, 8900
Sponsors and Collaborators
University of Aarhus
Study Director: Hans Svanholm, Head of department Region Hospital, Department of Pathology

Responsible Party: Else Toft Würtz, Student Identifier: NCT00526370     History of Changes
Other Study ID Numbers: TP07-2351
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: August 13, 2008
Last Verified: August 2008

Keywords provided by University of Aarhus:
self test
PAP smear
tampon test

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site