Intended Use Study of the BD SurePath Plus™ Pap
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
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 [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
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. [10 months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seattle Women's: Health, Research, Gynecology | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TPO-10-06084
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | All Enrolled Participants - Cervical cancer status was not known upon enrollment |
| Period Title: Overall Study | |
| STARTED | 5859 |
| COMPLETED | 5416 |
| NOT COMPLETED | 443 |
Baseline Characteristics
| Arm/Group Title | All Evaluable Participants |
|---|---|
| Arm/Group Description | All participants with satisfactory samples at completion of the study. |
| Overall Participants | 3731 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
3731
100%
|
| >=65 years |
0
0%
|
| Sex/Gender, Customized (Count of Participants) | |
| Female |
3731
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
889
23.8%
|
| Not Hispanic or Latino |
2842
76.2%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
3731
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All evaluable non-missing samples. |
| Arm/Group Title | SurePath Plus | SurePath Pap |
|---|---|---|
| Arm/Group Description | Samples tested on the SurePath Plus | Samples tested on the SurePath Pap |
| Measure Participants | 3731 | 3731 |
| Sensitivity (ASC-US+) |
84.9
|
71.4
|
| Specificity (ASC-US+) |
84.7
|
88.7
|
| PPV (ASC-US+) |
16.7
|
18.5
|
| NPV (ASC-US+) |
99.4
|
98.9
|
| Sensitivity (ASC-H+) |
65.5
|
43.7
|
| Specificity (ASC-H+) |
92.2
|
94.4
|
| PPV (ASC-H+) |
23.2
|
21.8
|
| NPV (ASC-H+) |
98.7
|
97.9
|
| Sensitivity (LSIL+) |
58.0
|
40.3
|
| Specificity (LSIL+) |
93.4
|
94.7
|
| PPV (LSIL+) |
24.0
|
21.4
|
| NPV (LSIL+) |
98.4
|
97.8
|
| Sensitivity (HSIL+) |
37.8
|
16.0
|
| Specificity (HSIL+) |
98.3
|
99.8
|
| PPV (HSIL+) |
45.0
|
76.0
|
| NPV (HSIL+) |
97.8
|
97.1
|
| 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. |
|---|---|
| Description | |
| Time Frame | 10 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable samples that had also had HPV reflex testing |
| Arm/Group Title | SurePath Plus With Immunostain | SurePath Pap With HPV |
|---|---|---|
| Arm/Group Description | Samples tested on the SurePath Plus | Samples tested on the SurePath Pap |
| Measure Participants | 221 | 221 |
| Sensitivity (ASC-US) |
78.8
|
87.9
|
| Specificity (ASC-US) |
45.7
|
41.5
|
Adverse Events
| Time Frame | 10 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Evaluable Participants | |
| Arm/Group Description | All participants with satisfactory samples at completion of the study. | |
All Cause Mortality |
||
| All Evaluable Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3731 (0%) | |
Serious Adverse Events |
||
| All Evaluable Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3731 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Evaluable Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3731 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Karen Yanson |
|---|---|
| Organization | Becton Dickinson |
| Phone | 410-316-4793 |
| karen_a_yanson@bd.com |
- TPO-10-06084