Trial Outcomes & Findings for Intended Use Study of the BD SurePath Plus™ Pap (NCT NCT01234480)
NCT ID: NCT01234480
Last Updated: 2023-05-16
Results Overview
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
Recruitment status
TERMINATED
Target enrollment
5859 participants
Primary outcome timeframe
10 months
Results posted on
2023-05-16
Participant Flow
Participant milestones
| Measure |
All Study Participants
All Enrolled Participants - Cervical cancer status was not known upon enrollment
|
|---|---|
|
Overall Study
STARTED
|
5859
|
|
Overall Study
COMPLETED
|
5416
|
|
Overall Study
NOT COMPLETED
|
443
|
Reasons for withdrawal
| Measure |
All Study Participants
All Enrolled Participants - Cervical cancer status was not known upon enrollment
|
|---|---|
|
Overall Study
Pregnancy
|
88
|
|
Overall Study
>36/Normal History
|
50
|
|
Overall Study
Age
|
3
|
|
Overall Study
HPV Vaccine History
|
28
|
|
Overall Study
HPV Vaccine after Enrollment
|
17
|
|
Overall Study
Hysterectomy
|
2
|
|
Overall Study
Hysterectomy post enrollment
|
1
|
|
Overall Study
Inclusion/Exclusion Violation
|
3
|
|
Overall Study
Informed Consent Form Violation
|
30
|
|
Overall Study
Incorrect Visit
|
3
|
|
Overall Study
No Florida Lab License
|
20
|
|
Overall Study
Out of Window
|
42
|
|
Overall Study
Sample Processing/Storage
|
92
|
|
Overall Study
Site Amendment prohibited colposcopy
|
11
|
|
Overall Study
Site/Subject non-compliance
|
44
|
|
Overall Study
Missing Sample
|
9
|
Baseline Characteristics
Intended Use Study of the BD SurePath Plus™ Pap
Baseline characteristics by cohort
| Measure |
All Evaluable Participants
n=3731 Participants
All participants with satisfactory samples at completion of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3731 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3731 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
889 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2842 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3731 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: All evaluable non-missing samples.
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
Outcome measures
| Measure |
SurePath Plus
n=3731 Participants
Samples tested on the SurePath Plus
|
SurePath Pap
n=3731 Participants
Samples tested on the SurePath Pap
|
|---|---|---|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
PPV (ASC-US+)
|
16.7 Percent
Interval 15.1 to 18.2
|
18.5 Percent
Interval 16.2 to 20.7
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
PPV (HSIL+)
|
45.0 Percent
Interval 36.5 to 53.3
|
76.0 Percent
Interval 56.9 to 88.3
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Sensitivity (ASC-US+)
|
84.9 Percent
Interval 77.4 to 90.2
|
71.4 Percent
Interval 62.7 to 78.8
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Specificity (ASC-US+)
|
84.7 Percent
Interval 83.5 to 85.9
|
88.7 Percent
Interval 87.5 to 89.7
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
NPV (ASC-US+)
|
99.4 Percent
Interval 99.0 to 99.6
|
98.9 Percent
Interval 98.5 to 99.1
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Sensitivity (ASC-H+)
|
65.5 Percent
Interval 56.6 to 73.5
|
43.7 Percent
Interval 35.1 to 52.7
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Specificity (ASC-H+)
|
92.2 Percent
Interval 91.2 to 93.1
|
94.4 Percent
Interval 93.5 to 95.1
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
PPV (ASC-H+)
|
23.2 Percent
Interval 20.1 to 26.3
|
21.8 Percent
Interval 17.8 to 26.1
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
NPV (ASC-H+)
|
98.7 Percent
Interval 98.3 to 99.0
|
97.9 Percent
Interval 97.6 to 98.2
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Sensitivity (LSIL+)
|
58.0 Percent
Interval 49.0 to 66.5
|
40.3 Percent
Interval 32.0 to 49.3
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Specificity (LSIL+)
|
93.4 Percent
Interval 92.5 to 94.2
|
94.7 Percent
Interval 93.8 to 95.4
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
PPV (LSIL+)
|
24.0 Percent
Interval 20.4 to 27.6
|
21.4 Percent
Interval 17.2 to 25.9
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
NPV (LSIL+)
|
98.4 Percent
Interval 98.1 to 98.7
|
97.8 Percent
Interval 97.5 to 98.1
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Sensitivity (HSIL+)
|
37.8 Percent
Interval 29.6 to 46.8
|
16.0 Percent
Interval 10.5 to 23.6
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
Specificity (HSIL+)
|
98.3 Percent
Interval 97.8 to 98.7
|
99.8 Percent
Interval 99.6 to 99.9
|
|
Sensitivity, Specificity, PPV, and NPV of BD SurePath Plus Pap Test for the Determination of Cervical Disease as Defined by CIN2 or Higher
NPV (HSIL+)
|
97.8 Percent
Interval 97.5 to 98.1
|
97.1 Percent
Interval 96.9 to 97.3
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: Evaluable samples that had also had HPV reflex testing
Outcome measures
| Measure |
SurePath Plus
n=221 Participants
Samples tested on the SurePath Plus
|
SurePath Pap
n=221 Participants
Samples tested on the SurePath Pap
|
|---|---|---|
|
Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.
Sensitivity (ASC-US)
|
78.8 percent
Interval 62.2 to 89.3
|
87.9 percent
Interval 72.7 to 92.5
|
|
Compare the Sensitivity and Specificity of the BD SurePath Plus Pap Test to the SurePath Pap With HPV Reflex Testing for CIN2+ Disease Detection.
Specificity (ASC-US)
|
45.7 percent
Interval 38.8 to 52.9
|
41.5 percent
Interval 34.7 to 48.6
|
Adverse Events
All Evaluable Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place