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 Type
OBSERVATIONAL
Enrollment
6,730
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
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.
Time frame: 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).
Time frame: 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.
Time frame: 3 years
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.
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.
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University of Alabama
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Jupiter, Florida, United States
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Lake Worth, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
...and 30 more locations
Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Time frame: 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.
Time frame: 3 years