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

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

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus; Cervical Neoplasms
• Intervention / Treatment: Device: BD HPV Assay on Viper LT; Procedure: Colposcopy

• Study Type: Observational
• Enrollment (Actual): 6730

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2V3J1
      • BioVision
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
    • Mobile, Alabama, United States, 36608
      • Mobile OB/GYN
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research of Arizona
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Center
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research
  • California
    • San Diego, California, United States, 92123
      • Women's Health Care Research Corp.
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Blueskies Center for Women
  • Florida
    • Jupiter, Florida, United States, 33458
      • Health Awareness Inc.
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trails, LLC
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Medical Network for Education & Research
    • Savannah, Georgia, United States, 31406
      • Fellows Research Alliance - Savannah
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Maryland
    • Sparks, Maryland, United States, 21152
      • BD 54 Loveton
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Virtua Phoenix OB/GYN
    • Neptune, New Jersey, United States, 07753
      • Meridian Health / Jersey Shore University Medical Center
    • Teterboro, New Jersey, United States, 07608
      • Quest Laboratories
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • TriCore
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Irvington, New York, United States, 10533
      • Research Pathology Associates, LLC
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Center for Women's Health of Lansdale
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia
    • West Reading, Pennsylvania, United States, 19611
      • Reading Health Physician Network
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Fellows Research Alliance - Bluffton
    • North Charleston, South Carolina, United States, 29406
      • James T. Martin Jr. OB/GYN
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research
  • Texas
    • San Antonio, Texas, United States, 78233
      • Center for Disease Detection, LLC
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians Research Options
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Research Pathology Associates
    • Virginia Beach, Virginia, United States, 23462
      • Tidewater Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BD VIPER LT	Device: BD HPV Assay on Viper LT; The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.; Procedure: Colposcopy; The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.	Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 in subjects over a three year period using the subjects' HPV status at baseline versus cytology status at baseline.	3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.	Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).	3 years
To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.	The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial lesion or malignancy) cytology and Human Papillovirus (HPV) Negative Patients.	Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 over a three year period for the population of women negative for intraepithelial lesions or malignancy (NILM) cytology and with Human Papillovirus (HPV) negative results.	3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial Lesion or Malignancy) cytology and Human Papillomavirus (HPV) Negative Patients.	Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).	3 years
Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.	The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.	3 years

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Study Director: Tobi Karchmer, MD, Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: BDS-USLHPV