Uterine Cervical NeoplasmNCT03020121
Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
A study testing Colposcopy/biopsy in people with Uterine Cervical Neoplasm, run by Becton, Dickinson and Company at 12 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasm
- What is being tested?
- Colposcopy/biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Nov 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Southwest Womens Health
Albuquerque, New Mexico, 87102
Tricore Reference Lab
Albuquerque, New Mexico, 87102
Research Pathology Associates
Charlotte, North Carolina, 22901
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80207
American Pathology Partners Inc.
Denver, Colorado, 80222
Indiana University
Indianapolis, Indiana, 46202
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Research Pathology Associates, LLC
Irvington, New York, 10533
Transgenomics
Omaha, Nebraska, 68164
Center for Disease Detection
San Antonio, Texas, 78233
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
About this study
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.
- Conditions
- Uterine Cervical Neoplasm
- Being tested
- Colposcopy/biopsy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colposcopy/biopsyProcedure or surgery
Colposcopy/biopsy will be performed on all subjects
| Study group | Role | What they receive |
|---|---|---|
| BD HPV assay on Viper LT | Experimental | 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.
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. Receives: Procedure: Colposcopy/biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Lower than anticipated rate of subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020121
- Sponsor's protocol ID
- BDS-USHPVPC-AC
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
- ClinicalTrials.gov ID
- NCT03020121
- Acronym / sponsor ID
- BDS-USHPVPC-AC
- Conditions
- Uterine Cervical Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower than anticipated rate of subject enrollment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD HPV assay on Viper LT | Experimental | Procedure: Colposcopy/biopsyThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colposcopy/biopsyColposcopy/biopsy will be performed on all subjects | Procedure or surgery | BD HPV assay on Viper LT |
Primary outcome
Sensitivity
Time frame: 18 months
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.
Specificity
Time frame: 18 months
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.
PositivePredictive Value
Time frame: 18 months
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.
Negative Predictive Value
Time frame: 18 Months
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.
Likelyhood ratio
Time frame: 18 months
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.
Absolute Risk
Time frame: 18 Months
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.
Relative Risk
Time frame: 18 Months
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.
Positive Percent Agreement
Time frame: 18 Months
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.
Negative PercentAgreement
Time frame: 18 months
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.
Non reportable rate
Time frame: 18 months
.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
Results and safety
The study was stopped early (reason given: Lower than anticipated rate of subject enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colposcopy/biopsy in people with Uterine Cervical Neoplasm, run by Becton, Dickinson and Company at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lower than anticipated rate of subject enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 18 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.