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CompletedNCT00973362Updated Jan 6, 2017Results posted

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

A Phase 3 interventional study of APTIMA HPV Assay and FDA-Approved HPV DNA Test in Human Papillomavirus Infection, sponsored by Gen-Probe, Incorporated. Completed at 17 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Gen-Probe, Incorporated · Phase 3, Interventional, and Screening

Phase
Phase 3
Study type
Interventional
Enrollment
12,896
Allocation
Non-randomized
Ages
21 Years and older
Sex
Female
01

Study summary

The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.

Read the detailed description

The primary objective of the clinical trial is to evaluate the APTIMA HPV Assay, using the TIGRIS System, in cervical cancer screening programs. This will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (HPV) types in women with known cervical disease status. The assay will be evaluated in sample populations of women with ASC-US Pap test results ("ASC-US results") and women 30 years of age or older ("30+ years of age") with negative (NILM) cytology results.

02

Conditions studied

  • Human Papillomavirus Infection

Keywords

  • Cervix Cancer
  • Cervical Intraepithelial Neoplasia (CIN)
  • Human Papillomavirus Virus (HPV)
  • APTIMA HPV Assay
  • FDA-Approved HPV DNA Test
  • TIGRIS DTS (direct tube sampling) System
  • Clinical Sensitivity (%)
  • Clinical Specificity (%)
  • Positive Predictive Value [PPV] (%)
  • Negative Predictive Value [NPV] (%)
  • Atypical Squamous Cells Undetermined Significance (ASC-US)
  • Relative Risk
03

In context

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 12,896 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Gen-Probe, Incorporated is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female 21 years or older (ASC-US study only)
  • Female 30 years or older (Adjunct and ASC-US studies)
  • Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
  • Ability to comprehend and sign an IRB-approved Informed Consent Form

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
  • Abnormal Pap test result in the past 12 months
  • Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
  • Known to be pregnant
  • Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
  • Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
  • Prior vaccination for HPV
05

Study design

Phase
Phase 3
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12,896 participants (actual)

Study arms

  • Other
    Adjunct (i.e. Normal Pap)

    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. A comparator FDA-Approved HPV DNA test is reported.

    Device: APTIMA HPV Assay · Device: FDA-Approved HPV DNA Test

  • Other
    ASC-US

    The ASC-US study will evaluate the APTIMA HPV Assay clinical performance 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). A comparator FDA-Approved HPV DNA test is reported. There is no follow-up period.

    Device: APTIMA HPV Assay · Device: FDA-Approved HPV DNA Test

Interventions

  • DeviceAPTIMA 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).

  • DeviceFDA-Approved HPV DNA Test

    A FDA-Approved HPV DNA Test is used as the comparator assay.

06

What researchers measure

Primary outcomes

  1. Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+

    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

  2. Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+

    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

Secondary outcomes

  1. ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)

    ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)

    Time frame: Baseline Evaluation

  2. ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)

    ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay

    Time frame: Baseline Evaluation

07

Results

Posted Jan 6, 2017

Participant flow

Baseline Evaluation
Participant flow — Baseline Evaluation
MilestoneAdjunct (i.e. Normal Pap)ASC-US
Started116441252
Evaluable for analysis10871958
Conclusive disease status819939
Completed108711029
Not completed773223
Withdrew: W/d, later determined to be ineligible250
Withdrew: No colposcopy visit620
Withdrew: Inevaluable686223
3-Year Follow-up
Participant flow — 3-Year Follow-up
MilestoneAdjunct (i.e. Normal Pap)ASC-US
Started108710
Completed108540
Not completed170
Withdrew: Lost to follow-up170

Outcome measures

PrimaryAdjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+

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
Reported as:
Number · participants
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
participantsAPTIMA HPV Assay
Assay Positive, CIN2+15
Assay Negative, CIN2+5
Assay Positive, No Disease299
Assay Negative, No Disease500
Statistical analysis
  • APTIMA HPV Assay · Sensitivity (%): 75.0 · 95% CI 53.1 to 88.8
  • APTIMA HPV Assay · Specificity (%): 62.6 · 95% CI 59.2 to 65.9
  • APTIMA HPV Assay · Positive predictive value [ppv] (%): 4.8 · 95% CI 3.4 to 5.8
  • APTIMA HPV Assay · Negative predictive value [npv] (%): 99.0 · 95% CI 98.1 to 99.6
  • APTIMA HPV Assay · Prevalence (%): 2.4
  • APTIMA HPV Assay · Relative risk: 4.8 · 95% CI 1.8 to 13.1The relative risk of CIN2+ is defined as the \[ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) \] .
PrimaryAdjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+

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
Reported as:
Number · participants
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
participantsFDA-Approved DNA Test
Assay Positive, CIN2+16
Assay Negative, CIN2+3
Assay Positive, No Disease401
Assay Negative, No Disease381
Statistical analysis
  • FDA-Approved DNA Test · Sensitivity (%): 84.2 · 95% CI 62.4 to 94.5
  • FDA-Approved DNA Test · Specificity (%): 48.7 · 95% CI 45.2 to 52.2
  • FDA-Approved DNA Test · Positive predictive value [ppv] (%): 3.8 · 95% CI 2.9 to 4.4
  • FDA-Approved DNA Test · Negative predictive value [npv] (%): 99.2 · 95% CI 98.1 to 99.8
  • FDA-Approved DNA Test · Prevalence (%): 2.4
  • FDA-Approved DNA Test · Relative risk: 4.9 · 95% CI 1.4 to 16.7The relative risk of CIN2+ is defined as the \[ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) \] .
SecondaryASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)

ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)

Time frame:
Baseline Evaluation
Reported as:
Number · participants
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
participantsAPTIMA HPV AssayFDA-Approved HPV DNA Test
Assay Positive, CIN2+7979
Assay Negative, CIN2+1210
Assay Positive, No Disease315343
Assay Negative, No Disease533433
Statistical analysis
  • APTIMA HPV Assay · Sensitivity(%): 86.8 · 95% CI 78.4 to 92.3
  • APTIMA HPV Assay · Specificty: 62.9 · 95% CI 59.6 to 66.0
  • APTIMA HPV Assay · Ppv: 20.1 · 95% CI 18.1 to 22.0
  • APTIMA HPV Assay · Npv: 97.8 · 95% CI 96.5 to 98.8
  • APTIMA HPV Assay · Prevalence (%): 9.7
SecondaryASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)

ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay

Time frame:
Baseline Evaluation
Reported as:
Number · participants
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
participantsFDA-Approved HPV DNA Test
Assay Positive, CIN2+79
Assay Negative, CIN2+10
Assay Positive, No Disease343
Assay Negative, No Disease433
Statistical analysis
  • FDA-Approved HPV DNA Test · Sensitivity (%): 88.8 · 95% CI 80.5 to 93.8
  • FDA-Approved HPV DNA Test · Specificity(%): 55.8 · 95% CI 52.3 to 59.3
  • FDA-Approved HPV DNA Test · Ppv(%): 18.7 · 95% CI 17.0 to 20.4
  • FDA-Approved HPV DNA Test · Npv(%): 97.7 · 95% CI 96.2 to 98.8
  • FDA-Approved HPV DNA Test · Prevalence(%): 10.3

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adjunct (i.e. Normal Pap)—0/11,644 (0%)0/11,644 (0%)
ASC-US—0/1,252 (0%)0/1,252 (0%)

Baseline characteristics

Baseline Evaluable Analysis Population

Age, Continuous
Age, Continuous(Years)Adjunct (i.e. Normal Pap)ASC-USTotal
Mean44.1 ± 10.133.8 ± 10.343.3 ± 10.5
Age, Customized
Age, Customized(participants)Adjunct (i.e. Normal Pap)ASC-USTotal
21 - <30 years0418418
30 - <40 years41992664465
40+ years66722746946
Gender
Gender(Participants)Adjunct (i.e. Normal Pap)ASC-USTotal
Female1087195811829
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Adjunct (i.e. Normal Pap)ASC-USTotal
Hispanic or Latino34211953616
Not Hispanic or Latino68817127593
Unknown or Not Reported56951620
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Adjunct (i.e. Normal Pap)ASC-USTotal
American Indian or Alaska Native761288
Asian62227649
Native Hawaiian or Other Pacific Islander48149
Black or African American13582181576
White68315667397
More than one race12828156
Unknown or Not Reported18081061914
Region of Enrollment
Region of Enrollment(participants)Adjunct (i.e. Normal Pap)ASC-USTotal
United States1087195811829
08

Study locations

17 sites
  • NEA Clinic Women's Clinic
    Jonesboro, Arkansas 72401, United States
  • San Fernando Valley Research
    Canoga Park, California 91306, United States
  • Healthcare Partners of Monterey Park
    Los Angeles, California 90015, United States
  • Diverse Research Solutions
    Oxnard, California 93030, United States
  • REMEK
    Pomona, California 91767, United States
  • West Coast OB-Gyn
    San Diego, California 92123, United States
  • HealthCare Partners
    Torrance, California 90503, United States
  • Penninsula Research Associates
    Torrance, California 90505, United States
  • Community Medical Research of South Florida
    Miami, Florida 33141, United States
  • Insignia Clinical Research
    Tampa, Florida 33613, United States
  • Emory University School of Medicine
    Atlanta, Georgia 30303, United States
  • Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
    Indianapolis, Indiana 46202, United States
  • Saginaw Valley Medical Research
    Saginaw, Michigan 48604, United States
  • PPS Clinical
    Chesterfield, Missouri 63017, United States
  • Planned Parenthood of Eastern Arkansas and Oklahoma
    Tulsa, Oklahoma 74105, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • Adams Patterson OB-GYN
    Memphis, Tennessee 38120, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00973362
Lead sponsor
Gen-Probe, Incorporated
Responsible party
Sponsor
First posted
Sep 9, 2009
Start date
Mar 2008
Primary completion
Jun 2013
Completion
Apr 2014
Results posted
Jan 6, 2017
Last update
Jan 6, 2017

Study contacts

Jennifer L Reid, PhD
study director · Gen-Probe, Incorporated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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