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

Information source: Becton, Dickinson and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Neoplasms; Human Papillomavirus

Intervention: BD HPV Assay on Viper LT (Device); Colposcopy (Procedure)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Becton, Dickinson and Company

Official(s) and/or principal investigator(s):
Tobi Karchmer, MD, Study Director, Affiliation: Becton, Dickinson and Company

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

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome:

Cumulative Incidence Rate for greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) over 3 years

Cumulative incidence of greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) over 3 years

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Subject enrolled into the protocol BDS-USHPV and identified as eligible for the

longitudinal protocol

- Subjects with a baseline adjudicated histopathololgy result of

- Subjects 25 or older with NILM cytology and negative HPV results not selected for

colpo biopsy visit during BDS-USHPV study 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

Locations and Contacts

University of Alabama, Birmingham, Alabama 35294, United States

Mobile OB/GYN, Mobile, Alabama 36608, United States

Women's Health Research of Arizona, Phoenix, Arizona 85015, United States

Quality of Life Medical & Research Center, Tucson, Arizona 85712, United States

Visions Clinical Research, Tucson, Arizona 85712, United States

Women's Health Care Research Corp., San Diego, California 92123, United States

Blueskies Center for Women, Colorado Springs, Colorado 80910, United States

Health Awareness Inc., Jupiter, Florida 33458, United States

Altus Research, Lake Worth, Florida 33461, United States

Segal Institute for Clinical Research, North Miami, Florida 33161, United States

Miami Research Associates, South Miami, Florida 33143, United States

Comprehensive Clinical Trails, LLC, West Palm Beach, Florida 33409, United States

Medical Network for Education & Research, Decatur, Georgia 30033, United States

Fellows Research Alliance - Savannah, Savannah, Georgia 31406, United States

Women's Health Practice, Champaign, Illinois 61820, United States

Indiana University, Indianapolis, Indiana 46202, United States

Four Rivers Clinical Research, Paducah, Kentucky 42003, United States

Louisiana State University, New Orleans, Louisiana 70112, United States

Saginaw Valley Medical Research, Saginaw, Michigan 48604, United States

Virtua Phoenix OB/GYN, Moorestown, New Jersey 08057, United States

Meridian Health / Jersey Shore University Medical Center, Neptune, New Jersey 07753, United States

Quest Laboratories, Teterboro, New Jersey 07608, United States

TriCore, Albuquerque, New Mexico 87102, United States

Montefiore Medical Center, Bronx, New York 10461, United States

Research Pathology Associates, LLC, Irvington, New York 10533, United States

Eastern Carolina Women's Center, New Bern, North Carolina 28562, United States

Lyndhurst Clinical Research, Winston-Salem, North Carolina 27103, United States

HWC Women's Research Center, Englewood, Ohio 45322, United States

Center for Women's Health of Lansdale, Lansdale, Pennsylvania 19446, United States

Clinical Research of Philadelphia, Philadelphia, Pennsylvania 19114, United States

Reading Health Physician Network, West Reading, Pennsylvania 19611, United States

BioVision, Outremont, Quebec H2V3J1, Canada

Fellows Research Alliance - Bluffton, Bluffton, South Carolina 29910, United States

James T. Martin Jr. OB/GYN, North Charleston, South Carolina 29406, United States

Chattanooga Medical Research, Chattanooga, Tennessee 37404, United States

Center for Disease Detection, LLC, San Antonio, Texas 78233, United States

Physicians Research Options, Draper, Utah 84020, United States

Research Pathology Associates, Charlottesville, Virginia 22901, United States

Tidewater Clinical Research, Virgina Beach, Virginia 23462, United States

Additional Information

Starting date: October 2014
Last updated: February 9, 2015

Page last updated: August 23, 2015

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