NCT00743626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,712

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

August 28, 2008

Last Update Submit

February 20, 2018

Conditions

Cervical Cancer

Keywords

Pap testHPVHealthy patients screened for cervical cancer tests.

Outcome Measures

Primary Outcomes (1)

  • To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required

    1st visit, 12 months, 18 months follow up

Study Arms (1)

1

OTHER

Healthy patients screened for cervical cancer

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

Interventions

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)

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Ability to speak and clearly understand English
  • Female patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Joan K Murphy, MD,FRCSC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2008

First Posted

August 29, 2008

Study Start

December 1, 2006

Primary Completion

August 1, 2008

Study Completion

January 1, 2011

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

CA(1)