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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: Uterine Cervical Neoplasms

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

Phase: N/A

Status: Active, not recruiting

Sponsored by: Becton, Dickinson and Company

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

Summary

The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.

Clinical Details

Official title: 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: Open Label, Primary Purpose: Diagnostic

Primary outcome:

Sensitivity of the BD HPV Assay for the detection of cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN)

Specificity of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN)

Positive Predictive Value (PPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN).

Negative Predictive Value (NPV) of the BD HPV Assay for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN).

Likelihood ratio for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN).

Absolute risk for the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN).

Relative Risk of the detection of cervical disease as defined by cervical intraepithelial neoplasia (CIN).

Positive percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene Hybrid Capture 2 (HC2) HPV test and PCR/Sequencing on both strands of the PCR amplicon (bidirectional sequencing)

Negative percent agreement of the BD HPV Assay as compared to a composite HPV comparator incorporating results for the Digene HC2 HPV test and Polymerase Chain Reaction (PCR)/Sequencing on both strands of the PCR amplicon (bidirectional sequencing).

Non-reportable rate of BD HPV test

Prevalence of the population for Cervical Intraepithelial Neoplasia (CIN)

Eligibility

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

Criteria:

Inclusion Criteria:

- Females who are >21 years of age

- Females who provide informed consent

Exclusion Criteria:

- Known pregnant

- Cervical cytology specimen collected within the last 4 months

- Prior complete or partial hysterectomy involving removal of cervix

- Application of chemical compounds to the cervical area 24 hour prior to study entry-

acetic acid, iodine, spermicide, douche, or anti-fungal medications

- Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been

performed in the last twelve months

- Enrolled in a cervical disease diagnostic trial since 2007.

Locations and Contacts

University of Alabama Birmingham, 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, Tuscon, Arizona 85712, United States

Visions Clinical Research, Tuscon, Arizona 85015, United States

West Coast Medical Research, San Diego, California 92123, United States

Women's Health Care Research Center, 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, 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 Trials, LLC, West Palm Beach, Florida 33409, United States

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

Fellows Research Associates - 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

Transgenomics, Omaha, Nebraska 68164, United States

Vitura / Phoenix, Moorestown, New Jersey 08057, United States

Meridian Health, Neptune, New Jersey 07753, United States

Quest, Teterboro, New Jersey 07608, United States

TriCore, Alburquerque, New Mexico 87102, United States

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

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

LabCorp, Burlington, North Carolina 27215, 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 Health 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 Physicians Network, West Reading, Pennsylvania 19611, United States

BioVision, Outremont, Quebec H2V3J1, Canada

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

James T Martin Jr, MD, North Charleston, South Carolina 29406, United States

Chattanooga Medical Research, Chattanooga, Tennessee 37404, United States

Center for Disease Detection (CDD), San Antonio, Texas 78233, United States

Physicians Research Options, Sandy, Utah 84070, United States

Research Pathology Associates, Charlottesville, Virginia 22901, United States

Tidewater Clinical, Virginia Beach, Virginia 23456, United States

Additional Information

Starting date: August 2013
Last updated: June 18, 2015

Page last updated: August 23, 2015

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