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Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

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ClinicalTrials.gov Identifier: NCT01944722
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : April 18, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

Brief Summary:
The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Device: BD Onclarity™ HPV assay on BD Viper™ LT Procedure: Colposcopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33858 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: BD Onclarity™ HPV assay on BD Viper™ LT
The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results.
Device: BD Onclarity™ HPV assay on BD Viper™ LT
The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD 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.

Procedure: Colposcopy
Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.




Primary Outcome Measures :
  1. Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater [ Time Frame: Up to 14 weeks ]
    Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ 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 (multiplied by 100).

  2. Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater [ Time Frame: Up to 14 weeks ]
    Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).

  3. Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater [ Time Frame: Up to 14 weeks ]
    Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).

  4. Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater [ Time Frame: Up to 14 weeks ]
    Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).

  5. Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). [ Time Frame: Up to 14 weeks ]
    Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.

  6. Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). [ Time Frame: Up to 14 weeks ]
    Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.

  7. Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). [ Time Frame: Up to 14 weeks ]
    The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.

  8. Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). [ Time Frame: Up to 14 weeks ]
    The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.

  9. Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). [ Time Frame: Up to 14 weeks ]
    The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.

  10. Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). [ Time Frame: Up to 14 weeks ]
    The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.

  11. Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). [ Time Frame: Up to 14 weeks ]
    Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.

  12. Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). [ Time Frame: Up to 14 weeks ]
    Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.

  13. Positive Percent Agreement of the BD Onclarity™ 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) [ Time Frame: Up to 14 weeks ]
    Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).

  14. Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing) [ Time Frame: Up to 14 weeks ]
    Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).

  15. Non-reportable Rate of the BD Onclarity™ HPV Test [ Time Frame: Up to 14 weeks ]
    Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.

  16. Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. [ Time Frame: Up to 14 weeks ]
    Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females who are >21 years of age
  • Females who provide informed consent

Exclusion Criteria:

  • Known pregnant
  • Cervical cytology specimen collected within the last 4 months
  • Prior complete or partial hysterectomy involving removal of cervix
  • Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
  • Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
  • Enrolled in a cervical disease diagnostic trial since 2007.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944722


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Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
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Study Director: Charles Cooper, MD Becton, Dickinson and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT01944722     History of Changes
Other Study ID Numbers: BDS-USHPV
First Posted: September 18, 2013    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: June 12, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female