Clinical trial · Interventional
Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
NCT03020121CI-TRIAL-00031477terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lower than anticipated rate of subject enrollment
Summary
Brief summary (as posted)
The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.
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 Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colposcopy/biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BD HPV assay on Viper LT
- description
- The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy/biopsy will be performed on all subjects.
- interventionNames
- Procedure: Colposcopy/biopsy
Primary outcomes (10)
- measure
- Sensitivity
- timeFrame
- 18 months
- description
- Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Sensitivity is calculated: Number of subjects with a positive BD 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. Similar for CIN3 or greater.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Females who are greater than or equal to 21 years of age, * Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result, * Females who provide informed consent Exclusion Criteria: * Known pregnant * Prior complete or partial hysterectomy involving removal of cervix * Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months * Colposcopy clinic referral patients
References
Publications (0)
Data not yet available
No reference posted for this study.