Study Stopped
Lower than anticipated rate of subject enrollment
Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
1 other identifier
interventional
28
2 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 11, 2017
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJanuary 31, 2018
January 1, 2018
6 months
January 11, 2017
January 29, 2018
Conditions
Outcome Measures
Primary Outcomes (10)
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
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
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
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
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
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
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
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
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
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
Study Arms (1)
BD HPV assay on Viper LT
EXPERIMENTALThe BD HPV specimen will be tested with the BD HPV assay on the 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. Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the 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. Colposcopy/biopsy will be performed on all subjects.
Interventions
Colposcopy/biopsy will be performed on all subjects
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80207, United States
American Pathology Partners Inc.
Denver, Colorado, 80222, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Transgenomics
Omaha, Nebraska, 68164, United States
Southwest Womens Health
Albuquerque, New Mexico, 87102, United States
Tricore Reference Lab
Albuquerque, New Mexico, 87102, United States
Research Pathology Associates, LLC
Irvington, New York, 10533, United States
Research Pathology Associates
Charlotte, North Carolina, 22901, United States
Center for Disease Detection
San Antonio, Texas, 78233, United States
BioVision
Outremont, Quebec, H2V 3J11, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2017
First Posted
January 13, 2017
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
January 31, 2018
Record last verified: 2018-01