Cervical CancerNCT00743626
Pap Smear Research Study
A study testing Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16) in people with Cervical Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,712 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Ability to speak and clearly understand English
- Female patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening
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.
- Conditions
- Cervical Cancer
- Being tested
- Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)
- Keywords
- Pap test, HPV, Healthy patients screened for cervical cancer tests.
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Healthy patients screened for cervical cancer Receives: Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required
Measured: 1st visit, 12 months, 18 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startDec 2006
- Primary completionAug 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan K Murphy, MD,FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743626
- Sponsor's protocol ID
- Pap Smear Study
- Status last verified
- Feb 2018
- First submitted
- 28 Aug 2008
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT00743626
- Acronym / sponsor ID
- Pap Smear Study
- Conditions
- Cervical Cancer
- Keywords
- Pap test, HPV, Healthy patients screened for cervical cancer tests.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,712 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Dec 2006 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16)Healthy patients screened for cervical cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Ability to speak and clearly understand English
- Female patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan K Murphy, MD,FRCSC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16) in people with Cervical Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.