Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing
This study is currently recruiting participants.
Verified August 2012 by Gen-Probe, Incorporated
Sponsor:
Gen-Probe, Incorporated
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01427023
First received: August 26, 2011
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.
These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
| Condition | Intervention |
|---|---|
|
Trichomonas Vaginalis |
Device: APTIMA Trichomonas vaginalis (ATV) Assay |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay |
Resource links provided by NLM:
Further study details as provided by Gen-Probe, Incorporated:
Primary Outcome Measures:
- Positive Percent Agreement Using the TIGRIS Instrument as a Reference. [ Time Frame: approximately one year ] [ Designated as safety issue: No ]Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
- Negative Percent Agreement Using the TIGRIS Instrument as a Reference. [ Time Frame: approximately one year ] [ Designated as safety issue: No ]Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Secondary Outcome Measures:
- Positivity Rate [ Time Frame: approximately one year ] [ Designated as safety issue: No ]Positivity Rate
Biospecimen Retention: Samples With DNA
urine specimen, vaginal swab specimen, endocervical swab specimen and PreservCyt specimen
| Estimated Enrollment: | 780 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: APTIMA Trichomonas vaginalis (ATV) Assay
APTIMA Trichomonas vaginalis (ATV) Assay
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.
Criteria
Inclusion Criteria:
- Subject must be female and attend a participating clinic
- Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had 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 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:
- Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s)
- Subject must be asymptomatic and undergoing screening evaluation for possible STDs
- Subject must be undergoing Pap screening
Exclusion Criteria:
- Subject took antibiotic medications within the last 14 days
- Subject already participated in the 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427023
Contacts
| Contact: Patty Law, MS | 858-731-5919 | patty.law@gen-probe.com |
Locations
| United States, Alabama | |
| University of Alabama, Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Jane Schwebke, MD 205-975-5665 schwebke@uab.edu | |
| Principal Investigator: Jane Schwebke, MD | |
| United States, Indiana | |
| Wishard Hospital - Indiana University School of Medicine | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Louisiana State University | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Stephanie Taylor, MD 504-658-2622 STaylo2@lsuhsc.edu | |
| Principal Investigator: Stephanie Taylor, MD | |
| United States, Massachusetts | |
| New England Center for Clinical Research | Recruiting |
| Fall River, Massachusetts, United States, 02720 | |
| Contact: Stephen Kasparian, MD 508-672-7450 skasparian@neccr.com | |
| Principal Investigator: Stephen S Kasparian, MD | |
| United States, North Carolina | |
| University of North Carolina, Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Marcia Hobbs, PhD 919-846-6893 marcia_hobbs@med.unc.edu | |
| Principal Investigator: Marcia Hobbs, PhD | |
| United States, Tennessee | |
| Geneuity Clinical Research Services | Active, not recruiting |
| Maryville, Tennessee, United States, 37804 | |
| United States, Texas | |
| Planned Parenthood Gulf Coast | Recruiting |
| Houston, Texas, United States, 77023 | |
| Contact: Paul Fine, MD 713-831-6553 paul.fine@pphset.org | |
| Principal Investigator: Paul Fine, MD | |
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: | NCT01427023 History of Changes |
| Other Study ID Numbers: | ATVPS-US11-001 |
| Study First Received: | August 26, 2011 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Gen-Probe, Incorporated:
|
APTIMA Trichomonas vaginalis Assay APTIMA trichomonas trichomonas vaginalis |
Additional relevant MeSH terms:
|
Trichomonas Infections Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013