Trial Outcomes & Findings for Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System (NCT NCT00973362)
NCT ID: NCT00973362
Last Updated: 2017-01-06
Results Overview
Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12896 participants
Primary outcome timeframe
Baseline Evaluation
Results posted on
2017-01-06
Participant Flow
Participant milestones
| Measure |
Adjunct (i.e. Normal Pap)
The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
ASC-US
The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period.
|
|---|---|---|
|
Baseline Evaluation
STARTED
|
11644
|
1252
|
|
Baseline Evaluation
Evaluable for Analysis
|
10871
|
958
|
|
Baseline Evaluation
Conclusive Disease Status
|
819
|
939
|
|
Baseline Evaluation
COMPLETED
|
10871
|
1029
|
|
Baseline Evaluation
NOT COMPLETED
|
773
|
223
|
|
3-Year Follow-up
STARTED
|
10871
|
0
|
|
3-Year Follow-up
COMPLETED
|
10854
|
0
|
|
3-Year Follow-up
NOT COMPLETED
|
17
|
0
|
Reasons for withdrawal
| Measure |
Adjunct (i.e. Normal Pap)
The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
ASC-US
The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period.
|
|---|---|---|
|
Baseline Evaluation
W/D, later determined to be ineligible
|
25
|
0
|
|
Baseline Evaluation
No colposcopy visit
|
62
|
0
|
|
Baseline Evaluation
Inevaluable
|
686
|
223
|
|
3-Year Follow-up
Lost to Follow-up
|
17
|
0
|
Baseline Characteristics
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
Baseline characteristics by cohort
| Measure |
Adjunct (i.e. Normal Pap)
n=10871 Participants
The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
ASC-US
n=958 Participants
The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
Total
n=11829 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
33.8 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
43.3 Years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
|
Age, Customized
21 - <30 years
|
0 participants
n=93 Participants
|
418 participants
n=4 Participants
|
418 participants
n=27 Participants
|
|
Age, Customized
30 - <40 years
|
4199 participants
n=93 Participants
|
266 participants
n=4 Participants
|
4465 participants
n=27 Participants
|
|
Age, Customized
40+ years
|
6672 participants
n=93 Participants
|
274 participants
n=4 Participants
|
6946 participants
n=27 Participants
|
|
Gender
Female
|
10871 Participants
n=93 Participants
|
958 Participants
n=4 Participants
|
11829 Participants
n=27 Participants
|
|
Gender
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3421 Participants
n=93 Participants
|
195 Participants
n=4 Participants
|
3616 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6881 Participants
n=93 Participants
|
712 Participants
n=4 Participants
|
7593 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
569 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
620 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
76 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
622 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
649 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
48 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1358 Participants
n=93 Participants
|
218 Participants
n=4 Participants
|
1576 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6831 Participants
n=93 Participants
|
566 Participants
n=4 Participants
|
7397 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
128 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
156 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1808 Participants
n=93 Participants
|
106 Participants
n=4 Participants
|
1914 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10871 participants
n=93 Participants
|
958 participants
n=4 Participants
|
11829 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline EvaluationAdjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Outcome measures
| Measure |
APTIMA HPV Assay
n=819 Participants
The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
FDA-Approved HPV DNA Test
FDA-Approved HPV DNA Test as Comparator
|
|---|---|---|
|
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Positive, CIN2+
|
15 participants
|
—
|
|
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Negative, CIN2+
|
5 participants
|
—
|
|
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Positive, No Disease
|
299 participants
|
—
|
|
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Negative, No Disease
|
500 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline EvaluationPopulation: 18 women with Aptima HPV results did not have FDA-Approved DNA test results due to insufficient volume of the cytology specimen for a N of 801 compared to a N of 819 for the Aptima HPV assay results.
Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Outcome measures
| Measure |
APTIMA HPV Assay
n=801 Participants
The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
FDA-Approved HPV DNA Test
FDA-Approved HPV DNA Test as Comparator
|
|---|---|---|
|
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Positive, CIN2+
|
16 participants
|
—
|
|
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Negative, CIN2+
|
3 participants
|
—
|
|
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Positive, No Disease
|
401 participants
|
—
|
|
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Assay Negative, No Disease
|
381 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline EvaluationASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)
Outcome measures
| Measure |
APTIMA HPV Assay
n=939 Participants
The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
FDA-Approved HPV DNA Test
n=865 Participants
FDA-Approved HPV DNA Test as Comparator
|
|---|---|---|
|
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Positive, CIN2+
|
79 participants
|
79 participants
|
|
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Negative, CIN2+
|
12 participants
|
10 participants
|
|
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Positive, No Disease
|
315 participants
|
343 participants
|
|
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Negative, No Disease
|
533 participants
|
433 participants
|
SECONDARY outcome
Timeframe: Baseline EvaluationPopulation: 74 women with Aptima HPV assay results did not have FDA-Approved HPV DNA test results primarily due to insufficient volume of the cytology specimen for an N of 865 results for the FDA-Approved HPV DNA assay compared to 939 results for the Aptima HPV assay.
ASC\_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay
Outcome measures
| Measure |
APTIMA HPV Assay
n=865 Participants
The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.
APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
|
FDA-Approved HPV DNA Test
FDA-Approved HPV DNA Test as Comparator
|
|---|---|---|
|
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Positive, CIN2+
|
79 participants
|
—
|
|
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Negative, CIN2+
|
10 participants
|
—
|
|
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Positive, No Disease
|
343 participants
|
—
|
|
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Assay Negative, No Disease
|
433 participants
|
—
|
Adverse Events
Adjunct (i.e. Normal Pap)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ASC-US
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
Restriction type: LTE60