Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay
Sponsor study identifier
observational
532
1 country
7
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
December 2013
Actual (reported)The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay. These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2011
Actual (reported)September 1, 2011
Actual (reported)August 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 2013
Actual (reported)December 2013
Actual (reported)Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
approximately one year
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
approximately one year
Positivity Rate
approximately one year
APTIMA Trichomonas vaginalis (ATV) Assay
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
Wishard Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
New England Center for Clinical Research
Fall River, Massachusetts, 02720, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Geneuity Clinical Research Services
Maryville, Tennessee, 37804, United States
Planned Parenthood Gulf Coast
urine specimen, vaginal swab specimen, endocervical swab specimen and PreservCyt specimen
Jennifer Reid, PhD
Gen-Probe, Incorporated
532 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2011
First Posted
September 1, 2011
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Houston, Texas, 77023, United States
Primary Completion
March 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
February 6, 2014
Record last verified: 2014-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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