Pap Smear Research Study
Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00743626
Collaborator
(none)
1,712
1
1
49
34.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1712 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening
Actual Study Start Date
:
Dec 1, 2006
Actual Primary Completion Date
:
Aug 1, 2008
Actual Study Completion Date
:
Jan 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1 Healthy patients screened for cervical cancer |
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)
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network - Toronto Western Hospital | Toronto | Ontario | Canada | M5T 2S8 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Joan K Murphy, MD,FRCSC, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00743626
Other Study ID Numbers:
- Pap Smear Study
First Posted:
Aug 29, 2008
Last Update Posted:
Feb 22, 2018
Last Verified:
Feb 1, 2018
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms: