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



Status:Enrolling by invitation
Conditions:Infectious Disease, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Reproductive
Healthy:No
Age Range:21 - Any
Updated:1/5/2019
Start Date:October 2014
End Date:May 2019

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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


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
We found this trial at
40
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Albuquerque, New Mexico 87102
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Birmingham, Alabama 35294
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Bluffton, South Carolina 29910
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Champaign, Illinois 61820
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Charlottesville, Virginia 22901
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Chattanooga, Tennessee 37404
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Draper, Utah 84020
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Irvington, New York 10533
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Mobile, Alabama 36608
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New Orleans, Louisiana 70112
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North Charleston, South Carolina 29406
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North Miami, Florida 33161
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Sparks, Maryland 21152
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Virginia Beach, Virginia 23456
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