Phase 3
Completed N=12,896
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
Source: ClinicalTrials.gov NCT00973362 ↗Enrolled (actual)
12,896
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+ — 15; 5; 299; 500 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+ |
15; 5; 299; 500 | — |
| PRIMARY Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+ |
16; 3; 401; 381 | — |
| SECONDARY ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies) |
79; 79; 12; 10; 315; 343 | — |
| SECONDARY ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies) |
79; 10; 343; 433 | — |
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT00973362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.