Clinical trial · Interventional
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
NCT01944722CI-TRIAL-00033286completedN/AResults 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 the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.
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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD Onclarity™ HPV assay on BD Viper™ LT | Device | — | UNRESOLVED |
| Colposcopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BD Onclarity™ HPV assay on BD Viper™ LT
- description
- The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results.
- interventionNames
- Device: BD Onclarity™ HPV assay on BD Viper™ LT
- Procedure: Colposcopy
Primary outcomes (16)
- measure
- Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
- timeFrame
- Up to 14 weeks
- description
- Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Females who are \>21 years of age * Females who provide informed consent Exclusion Criteria: * Known pregnant * Cervical cytology specimen collected within the last 4 months * Prior complete or partial hysterectomy involving removal of cervix * Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications * Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months * Enrolled in a cervical disease diagnostic trial since 2007.
References
Publications (3)
- DERIVEDStoler MH, Wright TC, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper C. HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal Cytology. Am J Clin Pathol. 2019 Mar 1;151(4):433-442. doi: 10.1093/ajcp/aqy169. PMID 30649177
- DERIVEDWright TC Jr, Stoler MH, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper CK. Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial. Am J Clin Pathol. 2019 Jan 1;151(1):53-62. doi: 10.1093/ajcp/aqy084. PMID 30189049
- DERIVEDStoler MH, Wright TC Jr, Parvu V, Vaughan L, Yanson K, Eckert K, Karchmer T, Kodsi S, Cooper CK. The Onclarity Human Papillomavirus Trial: Design, methods, and baseline results. Gynecol Oncol. 2018 Jun;149(3):498-505. doi: 10.1016/j.ygyno.2018.04.007. Epub 2018 Apr 19. PMID 29681462