Prospective Collection of Female and Male Specimens for PANTHER® System Testing
NCT ID: NCT01638637
Last Updated: 2013-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1492 participants
OBSERVATIONAL
2012-02-29
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Specimen Collection
APTIMA Assays; PANTHER System
APTIMA Assays; PANTHER System
Interventions
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APTIMA Assays; PANTHER System
APTIMA Assays; PANTHER System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board (IRB)-approved waiver for parental consent for minors)
In addition, the subject must meet at least one of the following criteria:
* The subject reports symptoms consistent with a suspected STI such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
* Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
* Subject is asymptomatic and undergoing screening evaluation for possible STIs
* Subject (female) is asymptomatic and undergoing a routine examination with a pelvic examination
Exclusion Criteria
* The subject took antibiotic medications within the last 21 days
* Subject already participated in this study
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
16 Years
ALL
Yes
Sponsors
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Gen-Probe, Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer Reid, PhD
Role: STUDY_DIRECTOR
Gen-Probe, Incorporated
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Anthony Mills MD Inc.
Los Angeles, California, United States
Benchmark Research
San Francisco, California, United States
Planned Parenthood Southern New England
New Haven, Connecticut, United States
AGA Clinical Trials
Hialeah, Florida, United States
Wishard Health Services
Indianapolis, Indiana, United States
Louisiana State University Health Sciences
New Orleans, Louisiana, United States
John Hopkins University
Baltimore, Maryland, United States
New England Center for Clinical Research - New Bedford Clinic
New Bedford, Massachusetts, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Laboratory Corporation of America
Burlington, North Carolina, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Molecular Pathology Laboratory Network, Inc.
Maryville, Tennessee, United States
Planned Parenthood Houston and Southeast Texas
Houston, Texas, United States
Tidewater Clinical Research, Inc. -Tidewater Physicians for Women
Norfolk, Virginia, United States
Countries
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Other Identifiers
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AC2PS-US12-001
Identifier Type: OTHER
Identifier Source: secondary_id
AGCPS-US11-002
Identifier Type: -
Identifier Source: org_study_id