Screening for Syphilis InfectionsSyphPocNCT00732355
Syph-Check Syphilis Antibody Point of Care (POC) Test
An observational study of Screening for Syphilis Infections, run by Healthcare Providers Direct, Inc. at 1 site in United States.
Trial summary
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Screening for Syphilis Infections
- What is being tested?
- Syph-Check POC
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Point of Care clinics and doctor's office that test routine patients (both male and female), i.e. STD clinics, planned parenthood, pre-marital, blood donors, pre-employment, and general populations from different geographic locations having varying prevalence populations.
Who may be able to join
- Men and Women will be eligible who:
- are 18 years of age or older;
- Routine "presumed uninfected" for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other STD disease conditions and infections, will be identified.
- Pregnant women in the first and third trimester
Who cannot join
- are under 18 years of age
- unwillingness to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.
Read the detailed description
The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test.
- Conditions
- Screening for Syphilis Infections
- Being tested
- Syph-Check POC
- Keywords
- syphilis
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syph-Check POCDevice
Also called RPR, TPPA, syphilis
Rapid membrane test for syphilis antibodies
| Study group | Role | What they receive |
|---|---|---|
| I | known syphilis infected patients Receives: Device: Syph-Check POC | |
| U | presumed uninfected patients Receives: Device: Syph-Check POC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
Measured: end of study
Secondary outcomes (1)
Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionSep 2010
Why it stopped: insufficient patient populations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening for Syphilis InfectionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthcare Providers Direct, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary L Lehnus, Ph.D., Study director, Lehnus & Associates Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732355
- Sponsor's protocol ID
- SY-101
- Acronym
- SyphPoc
- Status last verified
- Feb 2016
- First submitted
- 8 Aug 2008
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum
- ClinicalTrials.gov ID
- NCT00732355
- Acronym / sponsor ID
- SyphPoc / SY-101
- Conditions
- Screening for Syphilis Infections
- Keywords
- syphilis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient patient populations
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Healthcare Providers Direct, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Aug 2008 (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 study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.
Detailed description
The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | – | Device: Syph-Check POCknown syphilis infected patients |
| U | – | Device: Syph-Check POCpresumed uninfected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Point of Care clinics and doctor's office that test routine patients (both male and female), i.e. STD clinics, planned parenthood, pre-marital, blood donors, pre-employment, and general populations from different geographic locations having varying prevalence populations.
Key inclusion criteria (4 listed)
- Men and Women will be eligible who:
Key exclusion criteria (2 listed)
- are under 18 years of age
- unwillingness to give consent
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 |
|---|---|---|
| Syph-Check POCAlso: RPR, TPPA, syphilisRapid membrane test for syphilis antibodies | Device | I, U |
Primary outcome
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
Time frame: end of study
1 secondary outcome
Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible
Time frame: end of study
Results and safety
The study was stopped early (reason given: insufficient patient populations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Gary L Lehnus, Ph.D. study director
Lehnus & Associates Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screening for Syphilis Infections, run by Healthcare Providers Direct, Inc. at 1 site 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: insufficient patient populations). Results are not available in the source record.
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?
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests (time frame: end of study). 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 2 Mar 2016.