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

August 14, 2017 updated by: Gen-Probe, Incorporated

Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Infectious Diseases STD Program University of Alabama at Birmingham
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Florida
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Mount Vernon Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • John Hopkins University
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • New England Center for Clinical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7030
        • University of North Carolina Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Planned Parenthood Southeastern Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic
    • Texas
      • Houston, Texas, United States, 77023
        • Planned Parenthood Gulf Coast
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Tidewater Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Treatment
Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
approximately one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gen-Probe, Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Renee Wait, Gen-Probe, Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATVTS-US12-001
  • AC2PS-US12-002 (Other Identifier: Gen-Probe)
  • ATVPS-US12-001 (Other Identifier: Gen-Probe)
  • ATVTS-US12-003 (Other Identifier: Gen-Probe)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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