Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

Study Overview
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Brief Summary
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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

Official Title
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Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

Conditions
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Cervical Neoplasms, Human Papillomavirus

Intervention / Treatment
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* Device: BD HPV Assay on Viper LT
* Procedure: Colposcopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BD VIPER LT<br> | Device: BD HPV Assay on Viper LT<br>* The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.<br>Procedure: Colposcopy<br>* The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 3 years |