Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

Completed · Not applicable

Conditions studied: Uterine Cervical Neoplasms

In brief

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.

Key facts

Study ID

NCT01944722

Run by

Becton, Dickinson and Company

People needed

33858

Starts

2013-08-01

Expected to finish

2016-03-01

Last updated by the study team

2018-06-12

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Females who are >21 years of age
• Females who provide informed consent

You may not qualify if…

• 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.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Mobile OB/GYN — Mobile, Alabama, United States
• Women's Health Research of Arizona — Phoenix, Arizona, United States
• Quality of Life Medical & Research Center — Tucson, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• Women's Health Care Research Corp — San Diego, California, United States
• West Coast Medical Research — San Diego, California, United States
• Blueskies Center for Women — Colorado Springs, Colorado, United States
• Health Awareness Inc — Jupiter, Florida, United States
• Altus — Lake Worth, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Medical Network for Education and Research — Decatur, Georgia, United States
• Fellows Research Associates - Savannah — Savannah, Georgia, United States
• Women's Health Practice — Champaign, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Four Rivers Clinical Research — Paducah, Kentucky, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Saginaw Valley Medical Research — Saginaw, Michigan, United States
• Transgenomics — Omaha, Nebraska, United States
• Vitura / Phoenix — Moorestown, New Jersey, United States
• Meridian Health — Neptune City, New Jersey, United States
• Q Squared Solutions — Teterboro, New Jersey, United States
• TriCore Reference Laboratory — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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