Pap Smear Research Study

University Health Network, Toronto

Status: Completed

Conditions: Cervical Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00743626

Pap Smear Study

Details and patient eligibility

About

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.

Enrollment: 1,712 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,712 participants in 1 patient group

1

Other group

Description:

Healthy patients screened for cervical cancer

Treatment:

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