Prospective Collection of Female and Male Specimens for PANTHER® System Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01638637
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : October 17, 2013
Information provided by (Responsible Party):
Gen-Probe, Incorporated

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

Condition or disease Intervention/treatment
Chlamydia Infections Gonorrhea Device: APTIMA Assays; PANTHER System

Study Type : Observational
Actual Enrollment : 1492 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prospective Collection of Female First-catch Urine, Vaginal Swab, Cervical, and Endocervical Swab Specimens and Male Urethral Swab and First-catch Urine Specimens for Testing With the PANTHER® System
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Specimen Collection Device: APTIMA Assays; PANTHER System

Primary Outcome Measures :
  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 [ Time Frame: approximately one year ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Symptomatic and asymptomatic subjects at least 16 years of age.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01638637

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Anthony Mills MD Inc.
Los Angeles, California, United States, 90069
Benchmark Research
San Francisco, California, United States, 94102
United States, Connecticut
Planned Parenthood Southern New England
New Haven, Connecticut, United States, 06511
United States, Florida
AGA Clinical Trials
Hialeah, Florida, United States, 33012
United States, Indiana
Wishard Health Services
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University Health Sciences
New Orleans, Louisiana, United States, 70112
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
New England Center for Clinical Research - New Bedford Clinic
New Bedford, Massachusetts, United States, 02744
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, North Carolina
Laboratory Corporation of America
Burlington, North Carolina, United States, 27215
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7030
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Tennessee
Molecular Pathology Laboratory Network, Inc.
Maryville, Tennessee, United States, 37804
United States, Texas
Planned Parenthood Houston and Southeast Texas
Houston, Texas, United States, 77023
United States, Virginia
Tidewater Clinical Research, Inc. -Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Gen-Probe, Incorporated
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated

Responsible Party: Gen-Probe, Incorporated Identifier: NCT01638637     History of Changes
Other Study ID Numbers: AGCPS-US11-002
AC2PS-US12-001 ( Other Identifier: Gen-ProbeAC2PS-US12-001Eval of COMBO2 Assay On PANTHER System in Male Urine is testing protocol for AGCPS-US11-002 )
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Chlamydia Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Chlamydiaceae Infections