Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
This study is ongoing, but not recruiting participants.
Sponsor:
Gen-Probe, Incorporated
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01728103
First received: November 12, 2012
Last updated: September 15, 2014
Last verified: September 2014
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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: | October 2014 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728103
Locations
| 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
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: | September 15, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Chlamydia Infections Communicable Diseases Infection 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 |
ClinicalTrials.gov processed this record on February 25, 2015