Uterine Cervical NeoplasmsNCT01234480
Intended Use Study of the BD SurePath Plus™ Pap
A study testing BD SurePath Plus Pap test, BD SurePath Pap test and colposcopy with biopsy/ECC in people with Uterine Cervical Neoplasms and Uterine Cervical Cancer, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Uterine Cervical Cancer, Neoplasms, Squamous Cell
- What is being tested?
- BD SurePath Plus Pap test, BD SurePath Pap test and colposcopy with biopsy/ECC
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,859 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Study subjects must give voluntary written informed consent to participate in this study.
- Females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions.
- High-risk is defined as:
- Have had a previous high-risk HPV positive test in the last 5 years; or
- Have had an abnormal Pap test (ASC-US or higher) in the last 5 years; or
- Have not been screened for cervical cancer by either a Pap test or HPV test in the last 5 years.
Who cannot join
- Subjects who are 36 years of age or greater who are not high risk, and/or:
- Have not had an abnormal Pap in the last 5 years; or
- Have not had a positive HPV test in the last 5 years; or
- Have been screened in the last 5 years without an abnormal Pap or HPV result
- Subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). Subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time
- Subjects who have had a prior complete or partial hysterectomy involving removal of the cervix.
Show all 11Show fewer
- Subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc.
- Subjects on whom conization, LEEP, laser surgery, or cryosurgery has been performed within the past five months.
- Subjects currently undergoing radiation and/or chemotherapy.
- Subjects under the age of 18.
- Subjects who have previously received a HPV vaccine with any number of doses.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
About this study
This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).
Read the detailed description
This is a pivotal, multi-center in vitro diagnostic study comparing the BD SurePath Plus Pap test to current practice (cytologic examination utilizing the BD SurePath liquid-based Pap test with conjunctive HPV testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as CIN2+) in women.
The new BD SurePath Plus Pap Test combines a traditional Papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as CIN2+).
- Conditions
- Uterine Cervical Neoplasms, Uterine Cervical Cancer, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
- Being tested
- BD SurePath Plus Pap test, BD SurePath Pap test, colposcopy with biopsy/ECC, HPV DNA test
- Keywords
- Liquid based cytology, Surepath
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD SurePath Plus Pap testDevice
BD SurePath Plus Pap test
BD SurePath Pap testDevice
BD SurePath Plus Pap test
colposcopy with biopsy/ECCProcedure or surgery
Colposcopy with biopsy/ECC for subjects with 1)BD SurePath Pap NILM, but HPV positive, or 2) BD SurePath Plus Pap test result of ASC-US or higher 3)BD SurePath Pap ASC-US or higher
HPV DNA testDevice
Also called digene HC2 HPV DNA test
digene HC2 HPV DNA test
| Study group | Role | What they receive |
|---|---|---|
| Participants with Cervical Disease | Experimental | Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC. Receives: Device: BD SurePath Plus Pap test; Device: BD SurePath Pap test; Procedure: colposcopy with biopsy/ECC; Device: HPV DNA test |
| Participants without Cervical Disease | Experimental | Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC. Receives: Device: BD SurePath Plus Pap test; Device: BD SurePath Pap test; Device: HPV DNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher
Measured: 10 months
Secondary outcomes (1)
Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionAug 2012
Why it stopped: Decided not to pursue commercialization of the product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234480
- Sponsor's protocol ID
- TPO-10-06084
- Status last verified
- May 2023
- First submitted
- 14 Oct 2010
- Last updated
- 16 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intended Use Study of the BD SurePath Plus™ Pap
- ClinicalTrials.gov ID
- NCT01234480
- Acronym / sponsor ID
- TPO-10-06084
- Conditions
- Uterine Cervical Neoplasms, Uterine Cervical Cancer, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
- Keywords
- Liquid based cytology, Surepath
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decided not to pursue commercialization of the product
- Enrolment
- 5,859 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide data on the performance of the BD SurePath Plus™ Pap test for identifying high grade cervical disease. This study will be conducted with approximately 12,500 women undergoing routine cervical cancer screening, of whom women with abnormal cytology and/or positive HPV test will be selected to undergo colposcopy and biopsy/ECC. Subjects with abnormal cytology results with biopsy results of less than or equal to CIN1 or CIN2 untreated will be asked to return in 6-8 months for follow-up testing. Subjects may be asked to proceed to a longer-term follow-up study and undergo cytological evaluation annually for 3 years (separate study).
Detailed description
This is a pivotal, multi-center in vitro diagnostic study comparing the BD SurePath Plus Pap test to current practice (cytologic examination utilizing the BD SurePath liquid-based Pap test with conjunctive HPV testing) for the detection of cervical cancer and high-grade cervical disease (collectively referred to as CIN2+) in women.
The new BD SurePath Plus Pap Test combines a traditional Papanicolaou staining for cellular morphology, with brown nuclear immunostaining resulting from the over-expression of specific protein biomarkers, on one slide, to improve the detection of high-grade cervical disease and cervical cancer (collectively referred to as CIN2+).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Cervical Disease | Experimental | Device: BD SurePath Plus Pap test, Device: BD SurePath Pap test, Procedure: colposcopy with biopsy/ECC, Device: HPV DNA testParticipants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC. |
| Participants without Cervical Disease | Experimental | Device: BD SurePath Plus Pap test, Device: BD SurePath Pap test, Device: HPV DNA testParticipants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Study subjects must give voluntary written informed consent to participate in this study.
- Females ages 18 - 35 years, inclusive; or women at high- risk for cervical cancer or its precursor lesions.
- Have had a previous high-risk HPV positive test in the last 5 years; or
- Have had an abnormal Pap test (ASC-US or higher) in the last 5 years; or
- Have not been screened for cervical cancer by either a Pap test or HPV test in the last 5 years.
Key exclusion criteria (11 listed)
- Subjects who are 36 years of age or greater who are not high risk, and/or:
- Subjects known to be pregnant or planning to become pregnant prior to the potential six months follow-up visit (self-reported). Subjects who decide to become pregnant prior to the six-month follow up visit or found to be pregnant after the first visit, but prior to the six-month follow-up visit will be terminated from further study participation at that time
- Subjects who have had a prior complete or partial hysterectomy involving removal of the cervix.
- Subjects who have had an application of chemical compounds to the cervical area within the 24 hours prior to study entry, e.g., acetic acid, iodine, spermicide, douche, anti-fungal medications, etc.
- Subjects on whom conization, LEEP, laser surgery, or cryosurgery has been performed within the past five months.
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 |
|---|---|---|
| BD SurePath Plus Pap testBD SurePath Plus Pap test | Device | Participants with Cervical Disease, Participants without Cervical Disease |
| BD SurePath Pap testBD SurePath Plus Pap test | Device | Participants with Cervical Disease, Participants without Cervical Disease |
| colposcopy with biopsy/ECCColposcopy with biopsy/ECC for subjects with 1)BD SurePath Pap NILM, but HPV positive, or 2) BD SurePath Plus Pap test result of ASC-US or higher 3)BD SurePath Pap ASC-US or higher | Procedure or surgery | Participants with Cervical Disease |
| HPV DNA testAlso: digene HC2 HPV DNA testdigene HC2 HPV DNA test | Device | Participants with Cervical Disease, Participants without Cervical Disease |
Primary outcome
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Time frame: 10 months
Estimate the sensitivity, specificity, positive predictive value and negative predictive value of the BD SurePath Plus Pap test in detecting cervical disease as defined as CIN2 or higher
1 secondary outcome
Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.
Time frame: 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD SurePath Plus Pap test, BD SurePath Pap test and colposcopy with biopsy/ECC in people with Uterine Cervical Neoplasms and Uterine Cervical Cancer, run by Becton, Dickinson and Company at 1 site in United States.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 16 May 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher (time frame: 10 months). 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 16 May 2023.