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Pap Smear Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00743626
Recruitment Status : Unknown
Verified August 2008 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : August 29, 2008
Last Update Posted : August 29, 2008
Sponsor:
Information provided by:

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
Cervical Cancer Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : December 2006
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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


Contacts
Contact: Adrijana Pesevska, BS 416-603-5800 ext 3590 Adrijana.Pesevska@uhn.on.ca

Locations
Canada, Ontario
University Health Network - Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Adrijana Pesevska, BS    416-603-5800 ext 3590    Adrijana.Pesevska@uhn.on.ca   
Sub-Investigator: Jeff A Bloom, MD,CCFP,FCFP         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Joan K Murphy, MD,FRCSC University Health Network, Toronto
More Information

Responsible Party: Joan K. Murphy,MD,FRCSC; Head of Gynecological Oncology, 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: August 29, 2008
Last Verified: August 2008

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