Intended Use Study of the BD SurePath Plus™ Pap

May 15, 2023 updated by: Becton, Dickinson and Company
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5859

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Women's: Health, Research, Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • Subjects who are 36 years of age or greater who are not high risk, and/or:

    1. Have not had an abnormal Pap in the last 5 years; or
    2. Have not had a positive HPV test in the last 5 years; or
    3. 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Cervical Disease
Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
Device: BD SurePath Plus Pap test
BD SurePath Plus Pap test
Device: BD SurePath Pap test
BD SurePath Plus Pap test
Procedure: colposcopy with biopsy/ECC
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
Device: HPV DNA test
digene HC2 HPV DNA test
Other Names:
  • digene HC2 HPV DNA test
Experimental: Participants without Cervical Disease
Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.
Device: BD SurePath Plus Pap test
BD SurePath Plus Pap test
Device: BD SurePath Pap test
BD SurePath Plus Pap test
Device: HPV DNA test
digene HC2 HPV DNA test
Other Names:
  • digene HC2 HPV DNA test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPO-10-06084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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