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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00526370
First received: September 6, 2007
Last updated: August 12, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Phase
Normal Uterine Cervical Cytology
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
 Phase 0

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Sensitivity and specificity of the HPV test of the material from the tampon self-test [ Time Frame: Spring 2008 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tampon self-test from cervix


Enrollment: 72
Study Start Date: August 2007
Study Completion Date: July 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Women with at least moderate dysplasia in biopsies from cervix uteri
B
Women with only normal PAP-smears

  Eligibility

Ages Eligible for Study:   23 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526370

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

No publications provided

Responsible Party: Else Toft Würtz, Student
ClinicalTrials.gov Identifier: NCT00526370     History of Changes
Other Study ID Numbers: TP07-2351
Study First Received: September 6, 2007
Last Updated: August 12, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
self test
PAP smear
tampon test
 E6/E7
mRNA
HPV

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

ClinicalTrials.gov processed this record on May 21, 2013