Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

Stopped early · Not applicable

Conditions studied: Uterine Cervical Neoplasm

In brief

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.

Key facts

Study ID

NCT03020121

Run by

Becton, Dickinson and Company

People needed

28

Starts

2016-11-01

Expected to finish

2017-05-01

Last updated by the study team

2018-01-31

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Planned Parenthood of the Rocky Mountains — Denver, Colorado, United States
• American Pathology Partners Inc. — Denver, Colorado, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States
• Transgenomics — Omaha, Nebraska, United States
• Southwest Womens Health — Albuquerque, New Mexico, United States
• Tricore Reference Lab — Albuquerque, New Mexico, United States
• Research Pathology Associates, LLC — Irvington, New York, United States
• Research Pathology Associates — Charlotte, North Carolina, United States
• Center for Disease Detection — San Antonio, Texas, United States
• BioVision — Outremont, Quebec, Canada

Full record on ClinicalTrials.gov

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