Clinical trial · Observational
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
NCT02267876CI-TRIAL-00049914completedClinicalTrials.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 assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Neoplasms | Cervical Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD HPV Assay on Viper LT | Device | — | UNRESOLVED |
| Colposcopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BD VIPER LT
- interventionNames
- Device: BD HPV Assay on Viper LT
- Procedure: Colposcopy
Primary outcomes (3)
- measure
- Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.
- timeFrame
- 3 years
- description
- Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing \>=CIN2 or \>=CIN3 in subjects over a three year period using the subjects' HPV status at baseline versus cytology status at baseline.
- measure
- Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.
- timeFrame
- 3 years
- description
- Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated. Exclusion Criteria: * Subjects with prior complete or partial hysterectomy involving removal of the cervix * Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study * Year 3 visit can not exceed 3 years and 6 months from the baseline visit
References
Publications (0)
Data not yet available
No reference posted for this study.