Prospective Collection of Female and Male Specimens for PANTHER® System Testing
2 other identifiers
observational
1,492
1 country
16
Brief Summary
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 17, 2013
October 1, 2013
1.3 years
February 29, 2012
October 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
approximately one year
Study Arms (1)
Specimen Collection
Interventions
APTIMA Assays; PANTHER System
Eligibility Criteria
Symptomatic and asymptomatic subjects at least 16 years of age.
You may qualify if:
- The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had intercourse within the past 12 months)
- 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
You may not qualify if:
- A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Anthony Mills MD Inc.
Los Angeles, California, 90069, United States
Benchmark Research
San Francisco, California, 94102, United States
Planned Parenthood Southern New England
New Haven, Connecticut, 06511, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Wishard Health Services
Indianapolis, Indiana, 46202, United States
Louisiana State University Health Sciences
New Orleans, Louisiana, 70112, United States
John Hopkins University
Baltimore, Maryland, 21205, United States
New England Center for Clinical Research - New Bedford Clinic
New Bedford, Massachusetts, 02744, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Laboratory Corporation of America
Burlington, North Carolina, 27215, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599-7030, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Molecular Pathology Laboratory Network, Inc.
Maryville, Tennessee, 37804, United States
Planned Parenthood Houston and Southeast Texas
Houston, Texas, 77023, United States
Tidewater Clinical Research, Inc. -Tidewater Physicians for Women
Norfolk, Virginia, 23502, United States
Biospecimen
urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer Reid, PhD
Gen-Probe, Incorporated
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2012
First Posted
July 12, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2013
Study Completion
July 1, 2013
Last Updated
October 17, 2013
Record last verified: 2013-10