Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
- Conditions
- Uterine Cervical Neoplasms
- Interventions
- Device: BD Onclarity™ HPV assay on BD Viper™ LTProcedure: Colposcopy
- Registration Number
- NCT01944722
- Lead Sponsor
- Becton, Dickinson and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 33858
- Females who are >21 years of age
- Females who provide informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BD Onclarity™ HPV assay on BD Viper™ LT Colposcopy The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results. BD Onclarity™ HPV assay on BD Viper™ LT BD Onclarity™ HPV assay on BD Viper™ LT The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results.
- Primary Outcome Measures
Name Time Method Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). Up to 14 weeks Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). Up to 14 weeks The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). Up to 14 weeks Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater Up to 14 weeks Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). Up to 14 weeks The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). Up to 14 weeks Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater Up to 14 weeks Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). Up to 14 weeks The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing) Up to 14 weeks Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).
Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater Up to 14 weeks Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater Up to 14 weeks Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). Up to 14 weeks The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Positive Percent Agreement of the BD Onclarity™ HPV Assay as Compared to a Composite HPV Comparator Incorporating Results for the Digene Hybrid Capture 2 (HC2) HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing) Up to 14 weeks Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. Up to 14 weeks Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.
Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). Up to 14 weeks Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Non-reportable Rate of the BD Onclarity™ HPV Test Up to 14 weeks Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Center for Women's Health of Lansdale
🇺🇸Lansdale, Pennsylvania, United States
Reading Health Physicians Network
🇺🇸West Reading, Pennsylvania, United States
Mobile OB/GYN
🇺🇸Mobile, Alabama, United States
Tidewater Clinical
🇺🇸Virginia Beach, Virginia, 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
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
Women's Health Care Research Corp
🇺🇸San Diego, California, United States
Quality of Life Medical & Research Center
🇺🇸Tucson, Arizona, United States
Altus
🇺🇸Lake Worth, Florida, United States
Health Awareness Inc
🇺🇸Jupiter, Florida, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Vitura / Phoenix
🇺🇸Moorestown, New Jersey, United States
Meridian Health
🇺🇸Neptune, New Jersey, United States
Q Squared Solutions
🇺🇸Teterboro, New Jersey, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, United States
Saginaw Valley Medical Research
🇺🇸Saginaw, Michigan, United States
James T Martin Jr, MD
🇺🇸North Charleston, South Carolina, United States
Fellows Research Associates - Bluffton
🇺🇸Bluffton, South Carolina, United States
Chattanooga Medical Research
🇺🇸Chattanooga, Tennessee, United States
Physicians Research Options
🇺🇸Draper, Utah, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
West Coast Medical Research
🇺🇸San Diego, California, United States
Women's Health Practice
🇺🇸Champaign, Illinois, United States
TriCore Reference Laboratory
🇺🇸Albuquerque, New Mexico, United States
Research Pathology Associates, LLC
🇺🇸Irvington, New York, United States
LabCorp
🇺🇸Burlington, North Carolina, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
HWC Women's Research Center
🇺🇸Englewood, Ohio, United States
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Research Pathology Associates
🇺🇸Earlysville, Virginia, United States
Blueskies Center for Women
🇺🇸Colorado Springs, Colorado, United States
Women's Health Research of Arizona
🇺🇸Phoenix, Arizona, United States
Center for Disease Detection (CDD)
🇺🇸San Antonio, Texas, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Transgenomics
🇺🇸Omaha, Nebraska, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States