Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

Uterine Cervical Neoplasms Clinical Trial

Official title:

Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944722
• Other study ID #: BDS-USHPV
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2018
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33858
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Females who are >21 years of age

• Females who provide informed consent

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Device:
• BD Onclarity™ HPV assay on BD Viper™ LT
The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.

Procedure:
• Colposcopy
Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.

Locations

Country	Name	City	State
United States	TriCore Reference Laboratory	Albuquerque	New Mexico
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Fellows Research Associates - Bluffton	Bluffton	South Carolina
United States	Montefiore Medical Center	Bronx	New York
United States	LabCorp	Burlington	North Carolina
United States	Women's Health Practice	Champaign	Illinois
United States	Chattanooga Medical Research	Chattanooga	Tennessee
United States	Blueskies Center for Women	Colorado Springs	Colorado
United States	Medical Network for Education and Research	Decatur	Georgia
United States	Physicians Research Options	Draper	Utah
United States	Research Pathology Associates	Earlysville	Virginia
United States	HWC Women's Research Center	Englewood	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Research Pathology Associates, LLC	Irvington	New York
United States	Health Awareness Inc	Jupiter	Florida
United States	Altus	Lake Worth	Florida
United States	Center for Women's Health of Lansdale	Lansdale	Pennsylvania
United States	Mobile OB/GYN	Mobile	Alabama
United States	Vitura / Phoenix	Moorestown	New Jersey
United States	Meridian Health	Neptune	New Jersey
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Louisiana State University	New Orleans	Louisiana
United States	James T Martin Jr, MD	North Charleston	South Carolina
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Transgenomics	Omaha	Nebraska
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Clinical Research of Philadelphia	Philadelphia	Pennsylvania
United States	Women's Health Research of Arizona	Phoenix	Arizona
United States	Saginaw Valley Medical Research	Saginaw	Michigan
United States	Center for Disease Detection (CDD)	San Antonio	Texas
United States	West Coast Medical Research	San Diego	California
United States	Women's Health Care Research Corp	San Diego	California
United States	Fellows Research Associates - Savannah	Savannah	Georgia
United States	Miami Research Associates	South Miami	Florida
United States	Q Squared Solutions	Teterboro	New Jersey
United States	Quality of Life Medical & Research Center	Tucson	Arizona
United States	Visions Clinical Research	Tucson	Arizona
United States	Tidewater Clinical	Virginia Beach	Virginia
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Reading Health Physicians Network	West Reading	Pennsylvania
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater	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).	Up to 14 weeks
Primary	Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater	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).	Up to 14 weeks
Primary	Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater	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).	Up to 14 weeks
Primary	Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater	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).	Up to 14 weeks
Primary	Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).	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.	Up to 14 weeks
Primary	Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).	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.	Up to 14 weeks
Primary	Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).	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.	Up to 14 weeks
Primary	Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).	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.	Up to 14 weeks
Primary	Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).	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.	Up to 14 weeks
Primary	Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).	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.	Up to 14 weeks
Primary	Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).	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.	Up to 14 weeks
Primary	Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).	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.	Up to 14 weeks
Primary	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)	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).	Up to 14 weeks
Primary	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)	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).	Up to 14 weeks
Primary	Non-reportable Rate of the BD Onclarity™ HPV Test	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.	Up to 14 weeks
Primary	Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.	Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.	Up to 14 weeks