Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

Completed

Conditions studied: Cervical Neoplasms, Human Papillomavirus

In brief

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

Key facts

Study ID

NCT02267876

Run by

Becton, Dickinson and Company

People needed

6730

Starts

2014-10-01

Expected to finish

2019-05-01

Last updated by the study team

2021-02-08

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama — 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
• Blueskies Center for Women — Colorado Springs, Colorado, United States
• Health Awareness Inc. — Jupiter, Florida, United States
• Altus Research — 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 Trails, LLC — West Palm Beach, Florida, United States
• Medical Network for Education & Research — Decatur, Georgia, United States
• Fellows Research Alliance - 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
• BD 54 Loveton — Sparks, Maryland, United States
• Saginaw Valley Medical Research — Saginaw, Michigan, United States
• Virtua Phoenix OB/GYN — Moorestown, New Jersey, United States
• Meridian Health / Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Quest Laboratories — Teterboro, New Jersey, United States
• TriCore — Albuquerque, New Mexico, United States
• Research Pathology Associates, LLC — Irvington, New York, United States

Full record on ClinicalTrials.gov

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