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

Completed

• Conditions: Cervical Neoplasms; Human Papillomavirus
• Interventions: Device: BD HPV Assay on Viper LT; Procedure: Colposcopy

• 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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-20
• Primary Completion: 2018-12-12
• Study Completion: 2019-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6730

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BD VIPER LT	BD HPV Assay on Viper LT	-
BD VIPER LT	Colposcopy	-

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)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Mobile OB/GYN; 🇺🇸 Mobile, Alabama, United States

Tidewater Clinical Research; 🇺🇸 Virginia Beach, Virginia, United States

Quality of Life Medical & Research Center; 🇺🇸 Tucson, Arizona, United States

Visions Clinical Research; 🇺🇸 Tucson, Arizona, United States

Health Awareness Inc.; 🇺🇸 Jupiter, Florida, United States

Blueskies Center for Women; 🇺🇸 Colorado Springs, Colorado, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

Comprehensive Clinical Trails, LLC; 🇺🇸 West Palm Beach, Florida, United States

Segal Institute for Clinical Research; 🇺🇸 North Miami, Florida, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

Medical Network for Education & Research; 🇺🇸 Decatur, Georgia, United States

Fellows Research Alliance - Savannah; 🇺🇸 Savannah, Georgia, United States

Women's Health Practice; 🇺🇸 Champaign, Illinois, United States

Four Rivers Clinical Research; 🇺🇸 Paducah, Kentucky, United States

BD 54 Loveton; 🇺🇸 Sparks, Maryland, United States

Saginaw Valley Medical Research; 🇺🇸 Saginaw, Michigan, United States

Virtua Phoenix OB/GYN; 🇺🇸 Moorestown, New Jersey, United States

Meridian Health / Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Quest Laboratories; 🇺🇸 Teterboro, New Jersey, United States

TriCore; 🇺🇸 Albuquerque, New Mexico, United States

Eastern Carolina Women's Center; 🇺🇸 New Bern, North Carolina, United States

Research Pathology Associates, LLC; 🇺🇸 Irvington, New York, United States

HWC Women's Research Center; 🇺🇸 Englewood, Ohio, United States

Reading Health Physician Network; 🇺🇸 West Reading, Pennsylvania, United States

Center for Women's Health of Lansdale; 🇺🇸 Lansdale, Pennsylvania, United States

Clinical Research of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Fellows Research Alliance - Bluffton; 🇺🇸 Bluffton, South Carolina, United States

James T. Martin Jr. OB/GYN; 🇺🇸 North Charleston, South Carolina, United States

Chattanooga Medical Research; 🇺🇸 Chattanooga, Tennessee, United States

Physicians Research Options; 🇺🇸 Draper, Utah, United States

Research Pathology Associates; 🇺🇸 Charlottesville, Virginia, United States

BioVision; 🇨🇦 Montréal, Quebec, Canada

Women's Health Research of Arizona; 🇺🇸 Phoenix, Arizona, United States

Women's Health Care Research Corp.; 🇺🇸 San Diego, California, United States

Center for Disease Detection, LLC; 🇺🇸 San Antonio, Texas, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States