Clinical trial · Interventional
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
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
NCT00973362CI-TRIAL-00025367completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APTIMA HPV Assay | Device | — | UNRESOLVED |
| FDA-Approved HPV DNA Test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Adjunct (i.e. Normal Pap)
- description
- 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.
- interventionNames
- Device: APTIMA HPV Assay
- Device: FDA-Approved HPV DNA Test
- type
- OTHER
- label
- ASC-US
- description
- 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.
- interventionNames
- Device: APTIMA HPV Assay
- Device: FDA-Approved HPV DNA Test
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.