Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Pap Smear Research Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University Health Network, Toronto.
Recruitment status was:  Recruiting
Information provided by:
University Health Network, Toronto Identifier:
First received: August 28, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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 Intervention
Cervical Cancer
Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1712
Study Start Date: December 2006
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00743626

Contact: Adrijana Pesevska, BS 416-603-5800 ext 3590

Canada, Ontario
University Health Network - Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Adrijana Pesevska, BS    416-603-5800 ext 3590   
Sub-Investigator: Jeff A Bloom, MD,CCFP,FCFP         
Sponsors and Collaborators
University Health Network, Toronto
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 Identifier: NCT00743626     History of Changes
Other Study ID Numbers: Pap Smear Study
Study First Received: August 28, 2008
Last Updated: August 28, 2008

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female processed this record on May 25, 2017