Pap Smear Research Study

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)

Other

If positive (Pap smear, HPV and/or p16) patients will be scheduled for 3 colposcopy follow up visits (1,12,18 months)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2011
First posted: Aug 29, 2008
Registry last updated: Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed