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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Normal Uterine Cervical Cytology Uterine Cervical Dysplasia Uterine Cervical Neoplasms

Keywords

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self test PAP smear tampon test E6/E7 mRNA HPV

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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A

Women with at least moderate dysplasia in biopsies from cervix uteri

No interventions assigned to this group

B

Women with only normal PAP-smears

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Student

Principal Investigators

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Hans Svanholm, Head of department

Role: STUDY_DIRECTOR

Region Hospital, Department of Pathology

Locations

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Region Hospital Randers

Randers, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TP07-2351

Identifier Type: -

Identifier Source: org_study_id