Pap Smear Research Study

NCT ID: NCT00743626

Last Updated: 2018-02-22

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

Clinical Phase

NA

Total Enrollment

1712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-01-31

Brief Summary

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The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Healthy patients screened for cervical cancer

Group Type OTHER

Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)

Intervention Type OTHER

If positive (Pap smear, HPV and/or p16) patients will be scheduled for 3 colposcopy follow up visits (1,12,18 months)

Interventions

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Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)

If positive (Pap smear, HPV and/or p16) patients will be scheduled for 3 colposcopy follow up visits (1,12,18 months)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years and older
* Ability to speak and clearly understand English
* Female patients

Exclusion Criteria

* No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.)
* Women who have had Pap smears within the previous 10 months
* Women under the age of 18.
* Women who are pregnant.
* Inability to give informed consent in English
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan K Murphy, MD,FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Pap Smear Study

Identifier Type: -

Identifier Source: org_study_id

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