Cervical Cancer
Conditions
Keywords
Pap test, HPV, Healthy patients screened for cervical cancer tests.
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.
Interventions
OTHERDiagnostic 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)
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed