Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Gen-Probe, Incorporated
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01728103
First received: November 12, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.


Condition Intervention
Chlamydia Infections
Gonorrhea
Trichomonas Infections
Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays

Resource links provided by NLM:


Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease [ Time Frame: approximately one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

urine; endocervical and vaginal swabs


Estimated Enrollment: 2100
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Treatment Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.

Criteria

Inclusion Criteria:

  • The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal 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 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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728103

Contacts
Contact: Patty Law, MS 858-731-5919 patty.law@hologic.com

Locations
United States, Alabama
Infectious Diseases STD Program University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Charles River, PhD    205-975-5665    rivers@uab.edu   
Principal Investigator: Jane Schwebke, MD         
United States, California
Medical Center for Clinical Research Completed
San Diego, California, United States, 92108
United States, Florida
Healthcare Clinical Data Completed
North Miami, Florida, United States, 33161
United States, Georgia
Mount Vernon Clinical Research Completed
Sandy Springs, Georgia, United States, 30328
United States, Louisiana
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Cathy Camaratta    504-568-4132    ccamma@lsuhsc.edu   
Principal Investigator: Stephanie Taylor, MD         
United States, Maryland
John Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Mathilda Barnes    410-614-2044    mbarnes2@jhmi.edu   
Principal Investigator: Charlotte Gaydos, DrPH         
United States, Massachusetts
New England Center for Clinical Research Completed
Fall River, Massachusetts, United States, 02720
United States, North Carolina
University of North Carolina Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7030
Contact: Adriane Osborn       aosborn2@unch.unc.edu   
Principal Investigator: Marcia Hobbs, PhD         
Sub-Investigator: Arlene Seña-Soberano, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Grace Kim    513-636-7781    Grace.Kim@cchmc.org   
Principal Investigator: Lea Widdice, MD         
United States, Pennsylvania
Planned Parenthood Southeastern Pennsylvania Completed
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina Completed
Charleston, South Carolina, United States, 29425
United States, Tennessee
The Jackson Clinic Completed
Jackson, Tennessee, United States, 38305
United States, Texas
Planned Parenthood Gulf Coast Recruiting
Houston, Texas, United States, 77023
Contact: Melissa Farrell    713-831-6561    Melissa.farrell@ppgulfcoast.org   
Principal Investigator: Paul Fine, MD         
United States, Virginia
Tidewater Clinical Research Completed
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01728103     History of Changes
Other Study ID Numbers: ATVTS-US12-001, AC2PS-US12-002, ATVPS-US12-001, ATVTS-US12-003
Study First Received: November 12, 2012
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014