Pap Smear Research Study

University Health Network, Toronto1,712 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,712

Conditions

Cervical Cancer

Interventions

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

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required

Time frame: 1st visit, 12 months, 18 months follow up

Data from ClinicalTrials.gov

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