Back to results

Intended Use Study of the BD SurePath Plus™ Pap

Primary Purpose

Uterine Cervical Neoplasms, Uterine Cervical Cancer, Neoplasms, Squamous Cell

Status

Terminated

Phase

Locations

United States

Study Type

Interventional

Intervention

BD SurePath Plus Pap test

BD SurePath Pap test

colposcopy with biopsy/ECC

HPV DNA test

About this trial

This is an interventional diagnostic trial for Uterine Cervical Neoplasms focused on measuring Liquid based cytology, Surepath

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Seattle Women's: Health, Research, Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Participants with Cervical Disease

Participants without Cervical Disease

Arm Description

Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.

Full Information

NCT ID

NCT01234480

First Posted

October 14, 2010

Last Updated

May 15, 2023

Sponsor

Becton, Dickinson and Company

1. Study Identification

Unique Protocol Identification Number

NCT01234480

Brief Title

Intended Use Study of the BD SurePath Plus™ Pap

Official Title

Intended Use Study of the BD SurePath Plus™ Pap

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Decided not to pursue commercialization of the product

Study Start Date

September 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Becton, Dickinson and Company

4. Oversight

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief 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 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+).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Cervical Neoplasms, Uterine Cervical Cancer, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Papilloma

Keywords

Liquid based cytology, Surepath

7. Study Design

Primary Purpose

Diagnostic

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5859 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants with Cervical Disease

Arm Type

Experimental

Arm Description

Participants positive for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

Arm Title

Participants without Cervical Disease

Arm Type

Experimental

Arm Description

Participants negative for Cervical Disease (CIN2 or higher) as determined by adjudicated histology from biopsy/ECC.

Intervention Type

Device

Intervention Name(s)

BD SurePath Plus Pap test

Intervention Description

BD SurePath Plus Pap test

Intervention Type

Device

Intervention Name(s)

BD SurePath Pap test

Intervention Description

BD SurePath Plus Pap test

Intervention Type

Procedure

Intervention Name(s)

colposcopy with biopsy/ECC

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

HPV DNA test

Other Intervention Name(s)

digene HC2 HPV DNA test

Intervention Description

digene HC2 HPV DNA test

Primary Outcome Measure Information:

Title

Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher

Description

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

Time Frame

10 months

Secondary Outcome Measure Information:

Title

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. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

Facility Information:

Facility Name

Seattle Women's: Health, Research, Gynecology

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Intended Use Study of the BD SurePath Plus™ Pap

We'll reach out to this number within 24 hrs