Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
- Conditions
- Cervical NeoplasmsHuman Papillomavirus
- Registration Number
- NCT02267876
- Lead Sponsor
- Becton, Dickinson and Company
- Brief 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 baseline results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 6730
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients. 3 years Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients. 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.
To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology. 3 years The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
- Secondary Outcome Measures
Name Time Method 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. 3 years Absolute risk will be calculated as: (number of disease cases)/(number of patients at risk).
Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology. 3 years The sensitivity and specificity of HPV primary screening algorithms for identifying ≥ CIN2 and ≥ CIN3 using genotyping and cytology will be calculated.
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. 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 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.
Trial Locations
- Locations (40)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Mobile OB/GYN
🇺🇸Mobile, Alabama, United States
Women's Health Research of Arizona
🇺🇸Phoenix, Arizona, United States
Quality of Life Medical & Research Center
🇺🇸Tucson, Arizona, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
Women's Health Care Research Corp.
🇺🇸San Diego, California, United States
Blueskies Center for Women
🇺🇸Colorado Springs, Colorado, United States
Health Awareness Inc.
🇺🇸Jupiter, Florida, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Scroll for more (30 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States