Human Papillomavirus InfectionPhase 3NCT00973362
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
A Phase 3 study testing APTIMA HPV Assay and FDA-Approved HPV DNA Test in people with Human Papillomavirus Infection, run by Gen-Probe, Incorporated at 17 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- APTIMA HPV Assay and FDA-Approved HPV DNA Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,896 participants
- Where
- 17 sitesUnited States
- Study dates
- Mar 2008to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
San Fernando Valley Research
Canoga Park, California, 91306
PPS Clinical
Chesterfield, Missouri, 63017
Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
Indianapolis, Indiana, 46202
NEA Clinic Women's Clinic
Jonesboro, Arkansas, 72401
Healthcare Partners of Monterey Park
Los Angeles, California, 90015
Adams Patterson OB-GYN
Memphis, Tennessee, 38120
Community Medical Research of South Florida
Miami, Florida, 33141
Diverse Research Solutions
Oxnard, California, 93030
Temple University Hospital
Philadelphia, Pennsylvania, 19140
REMEK
Pomona, California, 91767
Saginaw Valley Medical Research
Saginaw, Michigan, 48604
West Coast OB-Gyn
San Diego, California, 92123
Insignia Clinical Research
Tampa, Florida, 33613
HealthCare Partners
Torrance, California, 90503
Penninsula Research Associates
Torrance, California, 90505
Planned Parenthood of Eastern Arkansas and Oklahoma
Tulsa, Oklahoma, 74105
About this study
Official title: Clinical Evaluation of the APTIMA® HPV Assay on the TIGRIS® DTS® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens
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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- APTIMA HPV Assay, FDA-Approved HPV DNA Test
- 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
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Atypical Squamous Cells of the Cervix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APTIMA HPV AssayDevice
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 TestDevice
A FDA-Approved HPV DNA Test is used as the comparator assay.
| Study group | Role | What they receive |
|---|---|---|
| Adjunct (i.e. Normal Pap) | Other | 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. Receives: Device: APTIMA HPV Assay; Device: FDA-Approved HPV DNA Test |
| ASC-US | Other | 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. Receives: Device: APTIMA HPV Assay; Device: FDA-Approved HPV DNA Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+
Measured: Baseline Evaluation
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+
Measured: Baseline Evaluation
Secondary outcomes (2)
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)
Measured: Baseline Evaluation
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
Measured: Baseline Evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12,896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gen-Probe, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer L Reid, PhD, Study director, Gen-Probe, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973362
- Sponsor's protocol ID
- 2007HPVASCUS30
- Status last verified
- Nov 2016
- First submitted
- 4 Sep 2009
- Last updated
- 6 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the APTIMA® HPV Assay on the TIGRIS® DTS® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens
- ClinicalTrials.gov ID
- NCT00973362
- Acronym / sponsor ID
- 2007HPVASCUS30
- Conditions
- 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 (%)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,896 participants (actual)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunct (i.e. Normal Pap) | Other | Device: APTIMA HPV Assay, Device: FDA-Approved HPV DNA TestThe 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. |
| ASC-US | Other | Device: APTIMA HPV Assay, Device: FDA-Approved HPV DNA TestThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APTIMA HPV AssayThe 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). | Device | ASC-US, Adjunct (i.e. Normal Pap) |
| FDA-Approved HPV DNA TestA FDA-Approved HPV DNA Test is used as the comparator assay. | Device | ASC-US, Adjunct (i.e. Normal Pap) |
Primary outcome
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Time frame: Baseline Evaluation
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+
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
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+
2 secondary outcomes
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Time frame: Baseline Evaluation
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Time frame: Baseline Evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Reid, PhD study director
Gen-Probe, Incorporated
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APTIMA HPV Assay and FDA-Approved HPV DNA Test in people with Human Papillomavirus Infection, run by Gen-Probe, Incorporated at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+ (time frame: Baseline Evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.