Pap Smear Research Study

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)

• Registration Number: NCT00743626
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-08
• Study First Submitted: 2008-08-28
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Completion: 2011-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1712

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)	Healthy patients screened for cervical cancer

Primary Outcome Measures

Name	Time	Method
To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required	1st visit, 12 months, 18 months follow up

Trial Locations

Locations (1)

University Health Network - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada