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Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System

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ClinicalTrials.gov Identifier: NCT00973362
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Human Papillomavirus Infection
Interventions Device: APTIMA HPV Assay
Device: FDA-Approved HPV DNA Test
Enrollment 12896
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adjunct (i.e. Normal Pap) ASC-US
Hide Arm/Group Description

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).

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.

Period Title: Baseline Evaluation
Started 11644 1252
Evaluable for Analysis 10871 958
Conclusive Disease Status 819 939
Completed 10871 1029
Not Completed 773 223
Reason Not Completed
W/D, later determined to be ineligible             25             0
No colposcopy visit             62             0
Inevaluable             686             223
Period Title: 3-Year Follow-up
Started 10871 0 [1]
Completed 10854 0
Not Completed 17 0
Reason Not Completed
Lost to Follow-up             17             0
[1]
ASC-US study arm did not have a follow-up period
Arm/Group Title Adjunct (i.e. Normal Pap) ASC-US Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 10871 958 11829
Hide Baseline Analysis Population Description
Baseline Evaluable Analysis Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10871 participants 958 participants 11829 participants
44.1  (10.1) 33.8  (10.3) 43.3  (10.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10871 participants 958 participants 11829 participants
21 - <30 years 0 418 418
30 - <40 years 4199 266 4465
40+ years 6672 274 6946
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10871 participants 958 participants 11829 participants
Female
10871
 100.0%
958
 100.0%
11829
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10871 participants 958 participants 11829 participants
Hispanic or Latino
3421
  31.5%
195
  20.4%
3616
  30.6%
Not Hispanic or Latino
6881
  63.3%
712
  74.3%
7593
  64.2%
Unknown or Not Reported
569
   5.2%
51
   5.3%
620
   5.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10871 participants 958 participants 11829 participants
American Indian or Alaska Native
76
   0.7%
12
   1.3%
88
   0.7%
Asian
622
   5.7%
27
   2.8%
649
   5.5%
Native Hawaiian or Other Pacific Islander
48
   0.4%
1
   0.1%
49
   0.4%
Black or African American
1358
  12.5%
218
  22.8%
1576
  13.3%
White
6831
  62.8%
566
  59.1%
7397
  62.5%
More than one race
128
   1.2%
28
   2.9%
156
   1.3%
Unknown or Not Reported
1808
  16.6%
106
  11.1%
1914
  16.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10871 participants 958 participants 11829 participants
10871 958 11829
1.Primary Outcome
Title Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Hide Description 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+
Time Frame Baseline Evaluation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APTIMA HPV Assay
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 819
Measure Type: Number
Unit of Measure: participants
Assay Positive, CIN2+ 15
Assay Negative, CIN2+ 5
Assay Positive, No Disease 299
Assay Negative, No Disease 500
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity (%)
Estimated Value 75.0
Confidence Interval (2-Sided) 95%
53.1 to 88.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity (%)
Estimated Value 62.6
Confidence Interval (2-Sided) 95%
59.2 to 65.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Positive Predictive Value [PPV] (%)
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
3.4 to 5.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative Predictive Value [NPV] (%)
Estimated Value 99.0
Confidence Interval (2-Sided) 95%
98.1 to 99.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevalence (%)
Estimated Value 2.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
1.8 to 13.1
Estimation Comments The relative risk of CIN2+ is defined as the [ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) ] .
2.Primary Outcome
Title Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Hide Description 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+
Time Frame Baseline Evaluation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FDA-Approved DNA Test
Hide Arm/Group Description:
A FDA-Approved HPV DNA Test is the comparator assay,
Overall Number of Participants Analyzed 801
Measure Type: Number
Unit of Measure: participants
Assay Positive, CIN2+ 16
Assay Negative, CIN2+ 3
Assay Positive, No Disease 401
Assay Negative, No Disease 381
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDA-Approved DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity (%)
Estimated Value 84.2
Confidence Interval (2-Sided) 95%
62.4 to 94.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FDA-Approved DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity (%)
Estimated Value 48.7
Confidence Interval (2-Sided) 95%
45.2 to 52.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FDA-Approved DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Positive Predictive Value [PPV] (%)
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
2.9 to 4.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FDA-Approved DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative Predictive Value [NPV] (%)
Estimated Value 99.2
Confidence Interval (2-Sided) 95%
98.1 to 99.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FDA-Approved DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevalence (%)
Estimated Value 2.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection FDA-Approved DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
1.4 to 16.7
Estimation Comments The relative risk of CIN2+ is defined as the [ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) ] .
3.Secondary Outcome
Title ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Hide Description ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)
Time Frame Baseline Evaluation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title APTIMA HPV Assay FDA-Approved HPV DNA Test
Hide Arm/Group Description:
APTIMA HPV Assay Performed on the Tigris System
FDA-Approved HPV DNA Test as Comparator
Overall Number of Participants Analyzed 939 865
Measure Type: Number
Unit of Measure: participants
Assay Positive, CIN2+ 79 79
Assay Negative, CIN2+ 12 10
Assay Positive, No Disease 315 343
Assay Negative, No Disease 533 433
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity(%)
Estimated Value 86.8
Confidence Interval (2-Sided) 95%
78.4 to 92.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificty
Estimated Value 62.9
Confidence Interval (2-Sided) 95%
59.6 to 66.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter PPV
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
18.1 to 22.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter NPV
Estimated Value 97.8
Confidence Interval (2-Sided) 95%
96.5 to 98.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection APTIMA HPV Assay
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevalence (%)
Estimated Value 9.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Hide Description ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay
Time Frame Baseline Evaluation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FDA-Approved HPV DNA Test
Hide Arm/Group Description:
FDA-Approved HPV DNA Test as Comparator
Overall Number of Participants Analyzed 865
Measure Type: Number
Unit of Measure: participants
Assay Positive, CIN2+ 79
Assay Negative, CIN2+ 10
Assay Positive, No Disease 343
Assay Negative, No Disease 433
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDA-Approved HPV DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity (%)
Estimated Value 88.8
Confidence Interval (2-Sided) 95%
80.5 to 93.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FDA-Approved HPV DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity(%)
Estimated Value 55.8
Confidence Interval (2-Sided) 95%
52.3 to 59.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FDA-Approved HPV DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter PPV(%)
Estimated Value 18.7
Confidence Interval (2-Sided) 95%
17.0 to 20.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FDA-Approved HPV DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter NPV(%)
Estimated Value 97.7
Confidence Interval (2-Sided) 95%
96.2 to 98.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FDA-Approved HPV DNA Test
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Prevalence(%)
Estimated Value 10.3
Estimation Comments [Not Specified]
Time Frame 5 years
Adverse Event Reporting Description 2 years for recruitment for Adjunct and ACS-US Arms with a 3 years follow-up period for the Adjunct Arm
 
Arm/Group Title Adjunct (i.e. Normal Pap) ASC-US
Hide Arm/Group Description

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).

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).

All-Cause Mortality
Adjunct (i.e. Normal Pap) ASC-US
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adjunct (i.e. Normal Pap) ASC-US
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11644 (0.00%)   0/1252 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adjunct (i.e. Normal Pap) ASC-US
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11644 (0.00%)   0/1252 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Vice President Clinical Affairs
Organization: Hologic, Inc.
Phone: 858-410-8000
Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT00973362     History of Changes
Other Study ID Numbers: 2007HPVASCUS30
First Submitted: September 4, 2009
First Posted: September 9, 2009
Results First Submitted: July 28, 2016
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017