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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267876
Other study ID # BDS-USLHPV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date May 2019

Study information

Verified date February 2021
Source Becton, Dickinson and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 6730
Est. completion date May 2019
Est. primary completion date December 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

Device:
BD HPV Assay on Viper LT
The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
Procedure:
Colposcopy
The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.

Locations

Country Name City State
Canada BioVision Montréal Quebec
United States TriCore Albuquerque New Mexico
United States University of Alabama Birmingham Alabama
United States Fellows Research Alliance - Bluffton Bluffton South Carolina
United States Montefiore Medical Center Bronx New York
United States Women's Health Practice Champaign Illinois
United States Research Pathology Associates Charlottesville Virginia
United States Chattanooga Medical Research Chattanooga Tennessee
United States Blueskies Center for Women Colorado Springs Colorado
United States Medical Network for Education & Research Decatur Georgia
United States Physicians Research Options Draper Utah
United States HWC Women's Research Center Englewood Ohio
United States Indiana University Indianapolis Indiana
United States Research Pathology Associates, LLC Irvington New York
United States Health Awareness Inc. Jupiter Florida
United States Altus Research Lake Worth Florida
United States Center for Women's Health of Lansdale Lansdale Pennsylvania
United States Mobile OB/GYN Mobile Alabama
United States Virtua Phoenix OB/GYN Moorestown New Jersey
United States Meridian Health / Jersey Shore University Medical Center Neptune New Jersey
United States Eastern Carolina Women's Center New Bern North Carolina
United States Louisiana State University New Orleans Louisiana
United States James T. Martin Jr. OB/GYN North Charleston South Carolina
United States Segal Institute for Clinical Research North Miami Florida
United States Four Rivers Clinical Research Paducah Kentucky
United States Clinical Research of Philadelphia Philadelphia Pennsylvania
United States Women's Health Research of Arizona Phoenix Arizona
United States Saginaw Valley Medical Research Saginaw Michigan
United States Center for Disease Detection, LLC San Antonio Texas
United States Women's Health Care Research Corp. San Diego California
United States Fellows Research Alliance - Savannah Savannah Georgia
United States Miami Research Associates South Miami Florida
United States BD 54 Loveton Sparks Maryland
United States Quest Laboratories Teterboro New Jersey
United States Quality of Life Medical & Research Center Tucson Arizona
United States Visions Clinical Research Tucson Arizona
United States Tidewater Clinical Research Virginia Beach Virginia
United States Comprehensive Clinical Trails, LLC West Palm Beach Florida
United States Reading Health Physician Network West Reading Pennsylvania
United States Lyndhurst Clinical Research Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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