Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
NCT ID: NCT01728103
Last Updated: 2017-08-16
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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TERMINATED
1336 participants
OBSERVATIONAL
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No Treatment
APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays
Interventions
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APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays
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 sexually transmissible infection (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 is asymptomatic and undergoing a routine examination with a pelvic examination
Exclusion Criteria
* 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
FEMALE
Yes
Sponsors
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Gen-Probe, Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Renee Wait
Role: STUDY_DIRECTOR
Gen-Probe, Incorporated
Locations
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Infectious Diseases STD Program University of Alabama at Birmingham
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Healthcare Clinical Data
North Miami, Florida, United States
Mount Vernon Clinical Research
Sandy Springs, Georgia, United States
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
New Orleans, Louisiana, United States
John Hopkins University
Baltimore, Maryland, United States
New England Center for Clinical Research
Fall River, Massachusetts, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, United States
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
Planned Parenthood Gulf Coast
Houston, Texas, United States
Tidewater Clinical Research
Norfolk, Virginia, United States
Countries
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Other Identifiers
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AC2PS-US12-002
Identifier Type: OTHER
Identifier Source: secondary_id
ATVPS-US12-001
Identifier Type: OTHER
Identifier Source: secondary_id
ATVTS-US12-003
Identifier Type: OTHER
Identifier Source: secondary_id
ATVTS-US12-001
Identifier Type: -
Identifier Source: org_study_id
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