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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Gen-Probe, Incorporated Identifier:
First received: November 12, 2012
Last updated: March 19, 2015
Last verified: March 2015
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
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: October 2015
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


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.

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 identifier: NCT01728103

United States, Alabama
Infectious Diseases STD Program University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
United States, Florida
Healthcare Clinical Data
North Miami, Florida, United States, 33161
United States, Georgia
Mount Vernon Clinical Research
Sandy Springs, Georgia, United States, 30328
United States, Louisiana
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
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
Fall River, Massachusetts, United States, 02720
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7030
United States, Ohio
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
The Jackson Clinic
Jackson, Tennessee, United States, 38305
United States, Texas
Planned Parenthood Gulf Coast
Houston, Texas, United States, 77023
United States, Virginia
Tidewater Clinical Research
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Gen-Probe, Incorporated
Study Director: Renee Wait Gen-Probe, Incorporated
  More Information

Responsible Party: Gen-Probe, Incorporated 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: March 19, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chlamydia Infections
Communicable Diseases
Trichomonas Infections
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Parasitic Diseases
Protozoan Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial processed this record on May 22, 2016