Clinical trial NCT02267876: Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Official title: Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Neoplasms
Human Papillomavirus
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 6730
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were selected from a baseline study BDS-USHPV, which included female healthy volunteers.

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


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over three years in Human Papillomavirus (HPV) Positive Patients.
timeFrame: 3 years
measure: Absolute Risk of Cervical Intraepithelial Neoplasia 2 and 3 (CIN2 and CIN3) over 3 years in Human Papillovirus (HPV) Positive Patients.
timeFrame: 3 years
measure: To evaluate different screening strategies using Human Papillovirus (HPV) results with 16/18/45 genotyping and cytology.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: Evaluate Different Screening Strategies Using HPV Results with Genotyping (other than 16/18/45) and Cytology.
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Mobile
country: United States
facility: Mobile OB/GYN
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research of Arizona
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: San Diego
country: United States
facility: Women's Health Care Research Corp.
state: California
city: Colorado Springs
country: United States
facility: Blueskies Center for Women
state: Colorado
city: Jupiter
country: United States
facility: Health Awareness Inc.
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trails, LLC
state: Florida
city: Decatur
country: United States
facility: Medical Network for Education & Research
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance - Savannah
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Sparks
country: United States
facility: BD 54 Loveton
state: Maryland
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research
state: Michigan
city: Moorestown
country: United States
facility: Virtua Phoenix OB/GYN
state: New Jersey
city: Neptune
country: United States
facility: Meridian Health / Jersey Shore University Medical Center
state: New Jersey
city: Teterboro
country: United States
facility: Quest Laboratories
state: New Jersey
city: Albuquerque
country: United States
facility: TriCore
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Irvington
country: United States
facility: Research Pathology Associates, LLC
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Lansdale
country: United States
facility: Center for Women's Health of Lansdale
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Health Physician Network
state: Pennsylvania
city: Bluffton
country: United States
facility: Fellows Research Alliance - Bluffton
state: South Carolina
city: North Charleston
country: United States
facility: James T. Martin Jr. OB/GYN
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: San Antonio
country: United States
facility: Center for Disease Detection, LLC
state: Texas
city: Draper
country: United States
facility: Physicians Research Options
state: Utah
city: Charlottesville
country: United States
facility: Research Pathology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research
state: Virginia
city: Montréal
country: Canada
facility: BioVision
state: Quebec
Study officials:
affiliation: Becton, Dickinson and Company
name: Tobi Karchmer, MD
role: STUDY_DIRECTOR
References: