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Pap Smear Research Study

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring Pap test, HPV, Healthy patients screened for cervical cancer tests.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University Health Network - Toronto Western Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Healthy patients screened for cervical cancer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 28, 2008
Last Updated
February 20, 2018
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00743626
Brief Title
Pap Smear Research Study
Official Title
Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2006 (Actual)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Pap test, HPV, Healthy patients screened for cervical cancer tests.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1712 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Healthy patients screened for cervical cancer
Intervention Type
Other
Intervention Name(s)
Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)
Intervention Description
If positive (Pap smear, HPV and/or p16) patients will be scheduled for 3 colposcopy follow up visits (1,12,18 months)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan K Murphy, MD,FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

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