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Pap Smear Research Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00743626
First received: August 28, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 28, 2008
Last Updated: August 28, 2008
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on May 19, 2013