Uterine Cervical NeoplasmsNCT01671462
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
An observational study of Uterine Cervical Neoplasms, run by Becton, Dickinson and Company at 2 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 SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- BD HPV assay on Viper LT
- Type of treatment
- Medical device
- How many people
- 1,365 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2012to Nov 2013
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study includes retrospectively (residual, frozen) collected SurePath or PreservCyt vials and prospectively collected BD cervical brushes in BD transport medium, and SurePath or PreservCyt vials from subjects who meet the inclusion criteria below.
Who may be able to join
- Referred to follow up due to one or more abnormal Pap or an HPV infection
- Subjects who have provided informed consent
- Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.
Who cannot join
- Known to be pregnant
- With prior complete or partial hysterectomy involving removal of cervix
- Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
- Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
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 SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.
Read the detailed description
This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems.
The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- BD HPV assay on Viper LT
- Keywords
- HPV, Cervical Cancer, Cervical Neoplasms
- 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.
BD HPV assay on Viper LTDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater
Measured: Nine months
Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.
Measured: Nine months
Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test.
Measured: Nine months
Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
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.
Measured: Nine months
Secondary outcomes (2)
The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
Positive percent agreement is calculated: The number of subjects with positive BD HPV test and positive results for the HC2 test and Roche Linear Array HPV divided by total of subjects with positive results for HC2 test and Roche Linear Array HPV.
Measured: 9 months
Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
Negative percent agreement is calculated: The number of subjects with negative BD HPV test and negative results for the HC2 test and Roche Linear Array HPV divided by total of subjects with negative results for HC2 test and Roche Linear Array HPV test.
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Observational
- Enrolment
- 1,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irene Hannet, MD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671462
- Sponsor's protocol ID
- MDX-11-EUHPV
- Status last verified
- Feb 2014
- First submitted
- 13 Jul 2012
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ejegod DM, Junge J, Franzmann M, Kirschner B, Bottari F, Sideri M, Sandri MT, Bonde J. Clinical and analytical performance of the BD Onclarity HPV assay for detection of CIN2+ lesions on SurePath samples. Papillomavirus Res. 2016 Dec;2:31-37. doi: 10.1016/j.pvr.2016.01.003. Epub 2016 Mar 2.
PubMed 29074183Ejegod DM, Rebolj M, Bonde J. Comparison of analytical and clinical performance of CLART HPV2 genotyping assay to Linear Array and Hybrid Capture 2: a split-sample study. BMC Cancer. 2015 Apr 2;15:216. doi: 10.1186/s12885-015-1223-z.
PubMed 25886410
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
- ClinicalTrials.gov ID
- NCT01671462
- Acronym / sponsor ID
- MDX-11-EUHPV
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- HPV, Cervical Cancer, Cervical Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,365 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Aug 2012 (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 SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.
Detailed description
This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems.
The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study includes retrospectively (residual, frozen) collected SurePath or PreservCyt vials and prospectively collected BD cervical brushes in BD transport medium, and SurePath or PreservCyt vials from subjects who meet the inclusion criteria below.
Key inclusion criteria (3 listed)
- Referred to follow up due to one or more abnormal Pap or an HPV infection
- Subjects who have provided informed consent
- Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.
Key exclusion criteria (4 listed)
- Known to be pregnant
- With prior complete or partial hysterectomy involving removal of cervix
- Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
- Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.
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 |
|---|---|---|
| BD HPV assay on Viper LT | Device | – |
Primary outcome
Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Time frame: Nine months
Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater
Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Time frame: Nine months
Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.
Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Time frame: Nine months
Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test.
Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Time frame: Nine months
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.
2 secondary outcomes
The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
Time frame: 9 months
Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test
Time frame: Nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
- Derived from this study: PubMed 29074183Ejegod DM, Junge J, Franzmann M, Kirschner B, Bottari F, Sideri M, Sandri MT, Bonde J. Clinical and analytical performance of the BD Onclarity HPV assay for detection of CIN2+ lesions on SurePath samples. Papillomavirus Res. 2016 Dec;2:31-37. doi: 10.1016/j.pvr.2016.01.003. Epub 2016 Mar 2.
- Derived from this study: PubMed 25886410Ejegod DM, Rebolj M, Bonde J. Comparison of analytical and clinical performance of CLART HPV2 genotyping assay to Linear Array and Hybrid Capture 2: a split-sample study. BMC Cancer. 2015 Apr 2;15:216. doi: 10.1186/s12885-015-1223-z.
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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.
Irene Hannet, MD study director
Becton, Dickinson and Company
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Becton, Dickinson and Company at 2 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: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. (time frame: Nine months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01671462, which also lists 2 linked publications.
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 20 Feb 2014.