Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 6/14/2018 |
| Start Date: | August 2013 |
| End Date: | March 2016 |
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.
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.
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.
We found this trial at
41
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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