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Pap Smear Research Study

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ClinicalTrials.gov Identifier: NCT00743626
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
Cervical Cancer Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1712 participants
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 : December 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743626


Locations
Canada, Ontario
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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00743626     History of Changes
Other Study ID Numbers: Pap Smear Study
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Keywords provided by University Health Network, Toronto:
Pap test
HPV
Healthy patients screened for cervical cancer tests.

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female