Human Papillomavirus InfectionAHPV-GTNCT01384370
APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results
An observational study of Human Papillomavirus Infection, run by Gen-Probe, Incorporated at 3 sites in United States.
Trial summary
In both the ASC-US Study and Adjunct Study populations, the objectives are to: evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- How many people
- 1,260 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: AHPV Assay positive results (~310 from subjects with a consensus histology result of <CIN2 or indeterminate disease status and 70 from subjects with CIN2+) * 150 randomly selected AHPV Assay negative samples from subjects with a consensus histology result of <CIN2 and All AHPV Assay negative samples from subjects with CIN2+ (~13 samples) * 300 from subjects with a consensus histology result of <CIN2 or indeterminate disease status, 15 from subjects with CIN2+, and 200 from subjects who did not attend the colposcopy visit) Approximately 150 randomly selected APTIMA HPV Assay negative samples from subjects with a consensus histology result of <CIN2 All APTIMA HPV Assay negative samples from subjects with CIN2+ (approximately 5 samples)
Who may be able to join
- • the subject attended a colposcopy visit, and
- the referral Pap sample had a valid APTIMA HPV Assay result, and
- the sample had an APTIMA HPV Assay positive result, or
- the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; "CIN2+"), or
- the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid APTIMA HPV Assay result, and
- the sample had an APTIMA HPV Assay positive result, or
- the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or
- the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of <CIN2 and was randomly selected for inclusion.
Who cannot join
- Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Laboratory Corporation of America
Burlington, North Carolina, 27215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
North Shore LIJ Health System Laboratories
Lake Success, New York, 11042
About this study
Official title: Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype 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
In both the ASC-US Study and Adjunct Study populations, the objectives are to:
- evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
- evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.
Read the detailed description
The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT Assay) is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with positive results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate between HPV 18-positive samples and HPV 45-positive samples. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination) may be tested with the AHPV-GT Assay either pre- or post-Pap processing. The assay is used with the TIGRIS DTS (TIGRIS) System.
In both the ASC-US Study and Adjunct Study populations, the objectives are to:
- evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
- evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.
- Conditions
- Human Papillomavirus Infection
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AHPV positive and negative subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45
Sensitivity (%) = TP/(TP + FN) x 100:
True Negative (TN): AHPVGT=Negative, Cervical Disease Status <CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status <CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay
Measured: 6 months
Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples
Specificity (%) = TN/(TN + FP) x100:
True Negative (TN): AHPVGT=Negative, Cervical Disease Status <CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status <CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gen-Probe, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadd S Lazarus, M.D., Study director, Gen-Probe, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384370
- Sponsor's protocol ID
- HPVGTS-US10-002
- Acronym
- AHPV-GT
- Status last verified
- Oct 2011
- First submitted
- 18 Feb 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype 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
- NCT01384370
- Acronym / sponsor ID
- AHPV-GT / HPVGTS-US10-002
- Conditions
- Human Papillomavirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In both the ASC-US Study and Adjunct Study populations, the objectives are to:
- evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
- evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.
Detailed description
The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT Assay) is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with positive results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate between HPV 18-positive samples and HPV 45-positive samples. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination) may be tested with the AHPV-GT Assay either pre- or post-Pap processing. The assay is used with the TIGRIS DTS (TIGRIS) System.
In both the ASC-US Study and Adjunct Study populations, the objectives are to:
- evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
- evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHPV positive and negative subjects | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AHPV Assay positive results (~310 from subjects with a consensus histology result of <CIN2 or indeterminate disease status and 70 from subjects with CIN2+) * 150 randomly selected AHPV Assay negative samples from subjects with a consensus histology result of <CIN2 and All AHPV Assay negative samples from subjects with CIN2+ (~13 samples) * 300 from subjects with a consensus histology result of <CIN2 or indeterminate disease status, 15 from subjects with CIN2+, and 200 from subjects who did not attend the colposcopy visit) Approximately 150 randomly selected APTIMA HPV Assay negative samples from subjects with a consensus histology result of <CIN2 All APTIMA HPV Assay negative samples from subjects with CIN2+ (approximately 5 samples)
Key inclusion criteria (8 listed)
- • the subject attended a colposcopy visit, and
Key exclusion criteria (1 listed)
- Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45
Time frame: 6 months
Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status <CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status <CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay
Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples
Time frame: 6 months
Specificity (%) = TN/(TN + FP) x100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status <CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status <CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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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.
Tadd S Lazarus, M.D. study director
Gen-Probe, Incorporated
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Gen-Probe, Incorporated at 3 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 8 inclusion and 1 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45 (time frame: 6 months). 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 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.