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

Human Papillomavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267876
• Other study ID #: BDS-USLHPV
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cervical Neoplasms
• Human Papillomavirus
• Uterine Cervical Neoplasms

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