Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
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| ClinicalTrials.gov Identifier: NCT01728103 |
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Recruitment Status :
Terminated
(Corporate decision to spend money on other development programs.)
First Posted : November 16, 2012
Last Update Posted : August 16, 2017
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Sponsor:
Gen-Probe, Incorporated
Information provided by (Responsible Party):
Gen-Probe, Incorporated
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Brief Summary:
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 or disease | Intervention/treatment |
|---|---|
| Chlamydia Infections Gonorrhea Trichomonas Infections | Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays |
| Study Type : | Observational |
| Actual Enrollment : | 1336 participants |
| 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 |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | July 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
| No Treatment |
Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays |
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 ]
Biospecimen Retention: Samples With DNA
urine; endocervical and vaginal swabs
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: | 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
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 ClinicalTrials.gov identifier (NCT number): 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: | Renee Wait | Gen-Probe, Incorporated |
| Responsible Party: | Gen-Probe, Incorporated |
| ClinicalTrials.gov Identifier: | NCT01728103 History of Changes |
| Other Study ID 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 ) |
| First Posted: | November 16, 2012 Key Record Dates |
| Last Update Posted: | August 16, 2017 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
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Infection Communicable Diseases Gonorrhea Trichomonas Infections Chlamydia Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Genital Diseases, Male Genital Diseases, Female Protozoan Infections Parasitic Diseases Chlamydiaceae Infections |