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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   Baseline Evaluation
    Adjunct (i.e. Normal Pap)   ASC-US
STARTED   11644   1252 
Evaluable for Analysis   10871   958 
Conclusive Disease Status   819   939 
COMPLETED   10871   1029 
NOT COMPLETED   773   223 
W/D, later determined to be ineligible                25                0 
No colposcopy visit                62                0 
Inevaluable                686                223 

Period 2:   3-Year Follow-up
    Adjunct (i.e. Normal Pap)   ASC-US
STARTED   10871   0 [1] 
COMPLETED   10854   0 
NOT COMPLETED   17   0 
Lost to Follow-up                17                0 
[1] ASC-US study arm did not have a follow-up period



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Evaluable Analysis Population

Reporting Groups
  Description
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).

Total Total of all reporting groups

Baseline Measures
   Adjunct (i.e. Normal Pap)   ASC-US   Total 
Overall Participants Analyzed 
[Units: Participants]
 10871   958   11829 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.1  (10.1)   33.8  (10.3)   43.3  (10.5) 
Age, Customized 
[Units: Participants]
     
21 - <30 years   0   418   418 
30 - <40 years   4199   266   4465 
40+ years   6672   274   6946 
Gender 
[Units: Participants]
Count of Participants
     
Female      10871 100.0%      958 100.0%      11829 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   10871   958   11829 


  Outcome Measures

1.  Primary:   Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+   [ Time Frame: Baseline Evaluation ]

2.  Primary:   Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+   [ Time Frame: Baseline Evaluation ]

3.  Secondary:   ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)   [ Time Frame: Baseline Evaluation ]

4.  Secondary:   ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)   [ Time Frame: Baseline Evaluation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: rainer.ziermann@hologic.com



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