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NCT00743626 Clinical Trial

Pap Smear Research Study

Cervical Cancer Clinical Trial

Official title:
Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00743626
Other study ID # Pap Smear Study
Secondary ID
Status Completed
Phase N/A
First received August 28, 2008
Last updated February 20, 2018
Start date December 2006
Est. completion date January 2011

Study information
Verified date February 2018
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1712
Est. completion date January 2011
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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)

Locations
Country Name City State
Canada University Health Network - Toronto Western Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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