Status:
COMPLETED
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Cervical Neoplasms
Human Papillomavirus
Eligibility:
FEMALE
21+ years
Brief Summary
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 neo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
6730 Patients enrolled
Trial Details
Trial ID
NCT02267876
Start Date
October 1 2014
End Date
May 1 2019
Last Update
February 8 2021
Active Locations (40)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Mobile OB/GYN
Mobile, Alabama, United States, 36608
3
Women's Health Research of Arizona
Phoenix, Arizona, United States, 85015
4
Quality of Life Medical & Research Center
Tucson, Arizona, United States, 85712