Cervical NeoplasmsNCT02267876
Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
An observational study of Cervical Neoplasms and Human Papillomavirus, run by Becton, Dickinson and Company at 40 sites in 2 countries.
Trial summary
The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV… 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
- Cervical Neoplasms, Human Papillomavirus
- What is being tested?
- BD HPV Assay on Viper LT and Colposcopy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 6,730 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Oct 2014to May 2019
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.
Who may be able to join
- Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated.
Who cannot join
- Subjects with prior complete or partial hysterectomy involving removal of the cervix
- Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
- Year 3 visit can not exceed 3 years and 6 months from the baseline visit
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States39 sites
TriCore
Albuquerque, New Mexico, 87102
University of Alabama
Birmingham, Alabama, 35294
Fellows Research Alliance - Bluffton
Bluffton, South Carolina, 29910
Women's Health Practice
Champaign, Illinois, 61820
Research Pathology Associates
Charlottesville, Virginia, 22901
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
Blueskies Center for Women
Colorado Springs, Colorado, 80910
Medical Network for Education & Research
Decatur, Georgia, 30033
Physicians Research Options
Draper, Utah, 84020
HWC Women's Research Center
Englewood, Ohio, 45322
Indiana University
Indianapolis, Indiana, 46202
Research Pathology Associates, LLC
Irvington, New York, 10533
Health Awareness Inc.
Jupiter, Florida, 33458
Altus Research
Lake Worth, Florida, 33461
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446
Mobile OB/GYN
Mobile, Alabama, 36608
Virtua Phoenix OB/GYN
Moorestown, New Jersey, 08057
Meridian Health / Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Louisiana State University
New Orleans, Louisiana, 70112
James T. Martin Jr. OB/GYN
North Charleston, South Carolina, 29406
Segal Institute for Clinical Research
North Miami, Florida, 33161
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
Women's Health Research of Arizona
Phoenix, Arizona, 85015
Saginaw Valley Medical Research
Saginaw, Michigan, 48604
Center for Disease Detection, LLC
San Antonio, Texas, 78233
Women's Health Care Research Corp.
San Diego, California, 92123
Fellows Research Alliance - Savannah
Savannah, Georgia, 31406
Miami Research Associates
South Miami, Florida, 33143
BD 54 Loveton
Sparks, Maryland, 21152
Quest Laboratories
Teterboro, New Jersey, 07608
Montefiore Medical Center
The Bronx, New York, 10461
Quality of Life Medical & Research Center
Tucson, Arizona, 85712
Visions Clinical Research
Tucson, Arizona, 85712
Tidewater Clinical Research
Virginia Beach, Virginia, 23462
Comprehensive Clinical Trails, LLC
West Palm Beach, Florida, 33409
Reading Health Physician Network
West Reading, Pennsylvania, 19611
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results
- Conditions
- Cervical Neoplasms, Human Papillomavirus
- Being tested
- BD HPV Assay on Viper LT, Colposcopy
- 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
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
ColposcopyProcedure or surgery
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
| Study group | Role | What they receive |
|---|---|---|
| BD VIPER LT | Not described Receives: Device: BD HPV Assay on Viper LT; Procedure: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.
Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 in subjects over a three year period using the subjects' HPV status at baseline versus cytology status at baseline.
Measured: 3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Measured: 3 years
To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.
The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
Measured: 3 years
Secondary outcomes (3)
Cumulative Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial lesion or malignancy) cytology and Human Papillovirus (HPV) Negative Patients.
Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 over a three year period for the population of women negative for intraepithelial lesions or malignancy (NILM) cytology and with Human Papillovirus (HPV) negative results.
Measured: 3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial Lesion or Malignancy) cytology and Human Papillomavirus (HPV) Negative Patients.
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Measured: 3 years
Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.
The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion12 Dec 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobi Karchmer, MD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267876
- Sponsor's protocol ID
- BDS-USLHPV
- Status last verified
- Feb 2021
- First submitted
- 14 Oct 2014
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
- ClinicalTrials.gov ID
- NCT02267876
- Acronym / sponsor ID
- BDS-USLHPV
- Conditions
- Cervical Neoplasms, Human Papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,730 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 20 Oct 2014 (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 assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD VIPER LT | – | Device: BD HPV Assay on Viper LT, Procedure: Colposcopy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.
Key inclusion criteria (1 listed)
- Subject enrolled into the protocol BDS-USHPV and identified as eligible for the longitudinal protocol • Subjects enrolled into protocol BDS-USHPV with a baseline colposcopy and biopsy procedure and not treated.
Key exclusion criteria (3 listed)
- Subjects with prior complete or partial hysterectomy involving removal of the cervix
- Subjects on whom conization, LEEP, cervical laser surgery, or cryosurgery has been performed since enrollment into the BDS-USHPV study
- Year 3 visit can not exceed 3 years and 6 months from the baseline visit
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 LTThe BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument. | Device | BD VIPER LT |
| ColposcopyThe colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy. | Procedure or surgery | BD VIPER LT |
Primary outcome
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.
Time frame: 3 years
Cumulative risk is a measure of the total risk that a certain event will happen during a given period of time. In this longitudinal study, it refers to the risk of developing >=CIN2 or >=CIN3 in subjects over a three year period using the subjects' HPV status at baseline versus cytology status at baseline.
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.
Time frame: 3 years
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.
Time frame: 3 years
The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
3 secondary outcomes
Cumulative Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial lesion or malignancy) cytology and Human Papillovirus (HPV) Negative Patients.
Time frame: 3 years
Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in NILM (Negative for Intraepithelial Lesion or Malignancy) cytology and Human Papillomavirus (HPV) Negative Patients.
Time frame: 3 years
Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.
Time frame: 3 years
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 8 Feb 2021.
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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.
Tobi Karchmer, MD study director
Becton, Dickinson and Company
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Neoplasms and Human Papillomavirus, run by Becton, Dickinson and Company at 40 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 1 inclusion and 3 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 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 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?
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients. (time frame: 3 years). The study lists 3 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 8 Feb 2021.