Trichomonas VaginalisNCT01427023
Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing
An observational study of Trichomonas Vaginalis, run by Gen-Probe, Incorporated at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trichomonas Vaginalis
- What is being tested?
- APTIMA Trichomonas vaginalis (ATV) Assay
- Type of treatment
- Medical device
- How many people
- 532 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Planned Parenthood Gulf Coast
Houston, Texas, 77023
Wishard Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202
Geneuity Clinical Research Services
Maryville, Tennessee, 37804
Louisiana State University
New Orleans, Louisiana, 70112
About this study
Official title: Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay
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.
- Conditions
- Trichomonas Vaginalis
- Being tested
- APTIMA Trichomonas vaginalis (ATV) Assay
- Keywords
- APTIMA Trichomonas vaginalis Assay, APTIMA, trichomonas, trichomonas vaginalis
- Medical subject headings
- Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APTIMA Trichomonas vaginalis (ATV) AssayDevice
APTIMA Trichomonas vaginalis (ATV) Assay
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
Measured: approximately one year
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Measured: approximately one year
Secondary outcomes (1)
Positivity Rate
Positivity Rate
Measured: approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichomonas VaginalisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gen-Probe, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Reid, PhD, Study director, Gen-Probe, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427023
- Sponsor's protocol ID
- ATVPS-US11-001
- Status last verified
- Feb 2014
- First submitted
- 26 Aug 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay
- ClinicalTrials.gov ID
- NCT01427023
- Acronym / sponsor ID
- ATVPS-US11-001
- Conditions
- Trichomonas Vaginalis
- Keywords
- APTIMA Trichomonas vaginalis Assay, APTIMA, trichomonas, trichomonas vaginalis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women attending participating US OB/GYN, family planning, or STD clinics will be eligible to participate.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APTIMA Trichomonas vaginalis (ATV) AssayAPTIMA Trichomonas vaginalis (ATV) Assay | Device | – |
Primary outcome
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
Time frame: approximately one year
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
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
1 secondary outcome
Positivity Rate
Time frame: approximately one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Reid, PhD study director
Gen-Probe, Incorporated
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trichomonas Vaginalis, run by Gen-Probe, Incorporated at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Percent Agreement Using the TIGRIS Instrument as a Reference. (time frame: approximately one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.