Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

Uterine Cervical Neoplasm Clinical Trial

Official title:

Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020121
• Other study ID #: BDS-USHPVPC-AC
• Status: Terminated
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 29, 2018
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: January 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) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Females who are greater than or equal to 21 years of age,

• Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result,

• Females who provide informed consent

Exclusion Criteria:

• Known pregnant

• Prior complete or partial hysterectomy involving removal of cervix

• Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months

• Colposcopy clinic referral patients

Related Conditions & MeSH terms

• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Colposcopy/biopsy
Colposcopy/biopsy will be performed on all subjects

Locations

Country	Name	City	State
Canada	BioVision	Outremont	Quebec
United States	Southwest Womens Health	Albuquerque	New Mexico
United States	Tricore Reference Lab	Albuquerque	New Mexico
United States	Research Pathology Associates	Charlotte	North Carolina
United States	American Pathology Partners Inc.	Denver	Colorado
United States	Planned Parenthood of the Rocky Mountains	Denver	Colorado
United States	Indiana University	Indianapolis	Indiana
United States	Sidney & Lois Eskenazi Hospital	Indianapolis	Indiana
United States	Research Pathology Associates, LLC	Irvington	New York
United States	Transgenomics	Omaha	Nebraska
United States	Center for Disease Detection	San Antonio	Texas
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Sensitivity is calculated: Number of subjects with a positive BD 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. Similar for CIN3 or greater.	18 months
Primary	Specificity	Specificity of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN). Specificity is calculated: Number of subjects with a negative BD HPV test with adjudicated histology results of less than CIN2 divided by the total number of subjects with adjudicated histology results of less than CIN2. Similar for CIN3 or greater.	18 months
Primary	PositivePredictive Value	Positive Predictive Value (PPV) of the BD 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 HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD HPV test. Similar for CIN3 or greater.	18 months
Primary	Negative Predictive Value	Negative Predictive Value (NPV) of the BD 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 HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD HPV test. Similar for CIN3 or greater.	18 Months
Primary	Likelyhood ratio	Likelihood ratio for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The likelihood ratio for each BD HPV test outcome summarizes how many times more (or less) likely subjects with the disease (e.g. CIN2 or greater and CIN3 or greater) are to have that particular HPV test outcome than subjects without the disease.	18 months
Primary	Absolute Risk	Absolute risk for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). The Absolute Risk (AR) of the disease(e.g., CIN2 or greater and CIN3 or greater) for each BD HPV test outcome is the probability of the disease for that particular BD HPV test outcome.	18 Months
Primary	Relative Risk	Relative Risk of the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN). Relative Risk is the ratio between two different absolute risks. The relative risk of having a disease (e.g., CIN2 or greater and CIN3 or greater), will be evaluated to compare two different BD HPV Assay test outcomes.	18 Months
Primary	Positive Percent Agreement	Positive percent agreement of the BD 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 HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive.	18 Months
Primary	Negative PercentAgreement	Negative percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene HC2 HPV test and Polymerase Chain Reaction (PCR)/Sequencing on both strands of the PCR amplicon (bidirectional sequencing). Negative percent agreement is calculated: Number of subjects with a negative BD HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative.	18 months
Primary	Non reportable rate	.Non-reportable rate of BD HPV test. Non-reportable rate is calculated as the number of non-reportable BD HPV test results divided by the total number of BD HPV test results	18 months