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

NCT03020121TerminatedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Becton, Dickinson and Company

Enrollment

Start Date

2016-11-01

Completion Date

2017-05-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Colposcopy/biopsy

Conditions

Uterine Cervical Neoplasm

Eligibility

Age Range

21 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: 18 months

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.

Time frame: 18 months

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.

Time frame: 18 months

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.

Time frame: 18 Months

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.

Time frame: 18 months

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.

Time frame: 18 Months

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.

Time frame: 18 Months

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.

Time frame: 18 Months

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.

Time frame: 18 months

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

Time frame: 18 months

Locations

Planned Parenthood of the Rocky Mountains, Denver, United States

American Pathology Partners Inc., Denver, United States

Comprehensive Clinical Trials, LLC, West Palm Beach, United States

Indiana University, Indianapolis, United States

Sidney & Lois Eskenazi Hospital, Indianapolis, United States

Transgenomics, Omaha, United States

Southwest Womens Health, Albuquerque, United States

Tricore Reference Lab, Albuquerque, United States

Research Pathology Associates, LLC, Irvington, United States

Research Pathology Associates, Charlotte, United States

Center for Disease Detection, San Antonio, United States

BioVision, Outremont, Canada