Lyme DiseaseLyTICNCT03201042
Lyme Test Indication Combinations (LyTIC) Study
An observational study of Lyme Disease, run by Oxford Immunotec at 60 sites in United States.
Trial summary
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- PCR based assay, Serology based assay and Tcell based assay
- How many people
- 410 participants
- Where
- 60 sitesUnited States
- Study dates
- 8 Jun 2017to 30 Nov 2018
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 500 subjects aged 5 years or older.
Who may be able to join
- Cohort 1a (typical EM and intention to treat):
- Documented new onset Lyme disease EM rash (single or multiple) with photographic evidence provided to Oxford Immunotec.
- Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
- Patients 5 years of age or older, with a minimum weight of 40 pounds.
- Patient able to read English and to give consent to study participation.
- If patient is younger than 18 years of age a legally authorized representative must provide consent.
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- Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
- Patients with suspected Lyme disease, based on physician's examination, where the physician has the intention to treat for Lyme disease (i.e. patients who following initial examination were prescribed treatment for Lyme disease).
- Documented new onset of Lyme disease symptoms without a typical EM rash or with no rash. If a rash is present, photographic evidence must be provided.
- Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
- Patients 5 years of age or older, with a minimum weight of 40 pounds.
- Patient able to read English and to give consent to study participation.
- If patient is younger than 18 years of age a legally authorized representative must provide consent.
- Cohort 2 (Healthy subjects):
- Subjects 5 years of age or older, with a minimum weight of 40 pounds.
- Subjects never diagnosed with any tick borne disease including Lyme disease
- Subjects able to read English and to give consent to study participation.
- If subject is younger than 18 years of age a legally authorized representative must provide consent.
Who cannot join
- Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
- Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
- Patients who received a Lyme vaccination.
- Patients with anemia defined as a serum hemoglobin <10gm/dL.
- Patients who are participating in, or plan to participate in, any investigational drug study.
- Patients who are considered unsuitable for the study by the Investigator.
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- Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
- Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
- Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
- Patients who received a Lyme vaccination.
- Patients with anemia defined as a serum hemoglobin <10gm/dL.
- Patients who are participating in, or plan to participate in, any investigational drug study.
- Patients who are considered unsuitable for the study by the Investigator.
- Cohort 2 (Healthy subjects):
- Subjects with a history of tick bite
- Subjects with past or current tick borne disease diagnosis
- Subjects at risk for tick borne diseases including Lyme disease
- Subjects residing in endemic regions for tick borne diseases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin.
- Subjects who have ever visited non-urban areas of endemic regions for tick borne diseases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Millennium Clincial Trials
Arlington, Virginia, 22207
Acadia Clinical Research
Bangor, Maine, 04401
Bally Medical Group
Barto, Pennsylvania, 19504
Andrea Gaito
Basking Ridge, New Jersey, 07920
Boyertown Medical Assoc.
Boyertown, Pennsylvania, 18512
Modern Medical
Brooklyn, New York, 11207
Private Practice-Johnathan Liebowitz
Brooklyn, New York, 11219
NY Arthritis Clinic
Brooklyn, New York, 12298
Burke Internal Medicine
Burke, Virginia, 22015
Rapid Medical Research
Cleveland, Ohio, 44122
Asthma and Allergy Institute of MI
Clinton Township, Michigan, 48038
Collegeville Family Practice
Collegeville, Pennsylvania, 19426
Buckeye Health and Research
Columbus, Ohio, 43207
Brandywine Clinic
Downingtown, Pennsylvania, 19335
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Pediatric Medical Associates of NTN/ABG
East Norriton, Pennsylvania, 19401
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Centennial Medical Group
Eldridge, Maryland, 21075
Regional Clinical Research, Inc.
Endwell, New York, 13760
Liberty Family Practice/Square 1
Erie, Pennsylvania, 16506
NECCR Primacare Research,LLC
Fall River, Massachusetts, 02721
MAffiliated Medical Associates
Florham Park, New Jersey, 07932
Private Practice-David Wurwitz
Flushing, New York, 11367
Delaware Integrated Medicine
Georgetown, Delaware, 19958
Adirondack Medical Research Center
Glens Falls, New York, 12801
Klein & Associates, MD, PA
Hagerstown, Maryland, 21740
Eastern Research, Inc.
Hialeah, Florida, 33013
South Florida Clinical Trials SFCT, A member of the Alliance, Inc.
Hialeah, Florida, 33016
Brookside Family Health Care
Hinesburg, Vermont, 05461
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Detweiler Family Practice
Lansdale, Pennsylvania, 19446
Green and Seidner Family Practice
Lansdale, Pennsylvania, 19446
Ocean State Clinical Research
Lincoln, Rhode Island, 02865
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501
Atascosa Clinical Trial
Lytle, Texas, 78052
Manassas Clinical Research Center
Manassas, Virginia, 21010
Suburban Research Assoc.
Media, Pennsylvania, 19063
Advance Clinical Research
Meridian, Idaho, 83642
South Coast Research Center
Miami, Florida, 33136
Exemplar Research
Morgantown, West Virginia, 26505
Metromedic Walk In
New Bedford, Massachusetts, 02740
Coastal Connecticut Research
New London, Connecticut, 06320
NYCT, A member of Alliance, Inc.
New York, New York, 10022
Mid Hudson Medical Research
Newburgh, New York, 12550
Circle CARE Center
Norwalk, Connecticut, 06850
MD Medical Research, Inc.
Oxon Hill, Maryland, 20745
John T. Mather Hospital
Port Jefferson, New York, 11777
Integrative Health Center of Maine
Portland, Maine, 01430
NECCR Primacare Research, LLC
Portsmouth, Rhode Island, 02871
Brookside Family Practice and Pediatrics
Pottstown, Pennsylvania, 19465
Paradigm Clinical Research
Redding, California, 96001
Rockville Internal Medicine Group
Rockville, Maryland, 20854
Spring-Ford Family Practice
Royersford, Pennsylvania, 19468
Pinnacle Research
Sartell, Minnesota, 56377
The Research Institute
Springfield, Massachusetts, 01105
Orthopaedic Foundation for Active Lifestyles, Inc
Stamford, Connecticut, 06905
Toledo Institute of Clinical Research
Toledo, Ohio, 43207
Oakland Medical Research
Troy, Michigan, 48085
NECCR Primacare Research, LLC
Westford, Massachusetts, 02790
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
About this study
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
Read the detailed description
The present study aims to investigate the performance characteristics of both established and new assays for Borrelia burgdorferi infection and to assess the relative performance of appropriate combinations of these tests. The study will also investigate the effect of the time course of the infection and its treatment on the outcomes for the various tests. Polymerase Chain Reaction(PCR), serology and T cell based tests will be performed. In addition, tests for Babesia, Anaplasma, Ehrlichia and Rickettsia will also be performed as these pathogens can be carried by the same tick that carries Borrelia and may result in coinfection.
- Conditions
- Lyme Disease
- Being tested
- PCR based assay, Serology based assay, Tcell based assay
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR based assayDiagnostic test
Whole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined.
In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen).
Serology based assayDiagnostic test
- The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b.
- The Immunetics C6 Lyme ELISA assay.
- A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines
- A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections.
Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared.
Tcell based assayDiagnostic test
A research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| 1a:Lyme patients- Erythema Migrans(EM)rash present | Patients with newly diagnosed Lyme disease based on the presence of a physician-documented EM rash. PCR, serology and Tcell based assay. Receives: Diagnostic Test: PCR based assay; Diagnostic Test: Serology based assay; Diagnostic Test: Tcell based assay | |
| 1b:Lyme patients no typical EM | Patients documented symptoms of early Lyme disease, without a typical EM rash present, and the physician's intention to treat for Lyme disease. PCR, serology and Tcell based assay Receives: Diagnostic Test: PCR based assay; Diagnostic Test: Serology based assay; Diagnostic Test: Tcell based assay | |
| Cohort 2: healthy controls | Patients drawn from Lyme disease non-endemic areas and subjects with known exposure to Lyme disease will be excluded. PCR, serology and Tcell based assay. Receives: Diagnostic Test: PCR based assay; Diagnostic Test: Serology based assay; Diagnostic Test: Tcell based assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample Data Analysis
The results will be used to calculate performance, including sensitivity and specificity of the tests under evaluation. The utility of these tests at different time points post initial presentation will be evaluated.
Measured: Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start8 Jun 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies 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
- Prospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Immunotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201042
- Sponsor's protocol ID
- L3
- Acronym
- LyTIC
- Status last verified
- Jun 2018
- First submitted
- 21 Jun 2017
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyme Test Indication Combinations (LyTIC) Study
- ClinicalTrials.gov ID
- NCT03201042
- Acronym / sponsor ID
- LyTIC / L3
- Conditions
- Lyme Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Oxford ImmunotecIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- 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.
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
Detailed description
The present study aims to investigate the performance characteristics of both established and new assays for Borrelia burgdorferi infection and to assess the relative performance of appropriate combinations of these tests. The study will also investigate the effect of the time course of the infection and its treatment on the outcomes for the various tests. Polymerase Chain Reaction(PCR), serology and T cell based tests will be performed. In addition, tests for Babesia, Anaplasma, Ehrlichia and Rickettsia will also be performed as these pathogens can be carried by the same tick that carries Borrelia and may result in coinfection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1a:Lyme patients- Erythema Migrans(EM)rash present | – | Diagnostic Test: PCR based assay, Diagnostic Test: Serology based assay, Diagnostic Test: Tcell based assayPatients with newly diagnosed Lyme disease based on the presence of a physician-documented EM rash. PCR, serology and Tcell based assay. |
| 1b:Lyme patients no typical EM | – | Diagnostic Test: PCR based assay, Diagnostic Test: Serology based assay, Diagnostic Test: Tcell based assayPatients documented symptoms of early Lyme disease, without a typical EM rash present, and the physician's intention to treat for Lyme disease. PCR, serology and Tcell based assay |
| Cohort 2: healthy controls | – | Diagnostic Test: PCR based assay, Diagnostic Test: Serology based assay, Diagnostic Test: Tcell based assayPatients drawn from Lyme disease non-endemic areas and subjects with known exposure to Lyme disease will be excluded. PCR, serology and Tcell based assay. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 500 subjects aged 5 years or older.
Key inclusion criteria (18 listed)
- Cohort 1a (typical EM and intention to treat):
- Documented new onset Lyme disease EM rash (single or multiple) with photographic evidence provided to Oxford Immunotec.
- Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
- Patients 5 years of age or older, with a minimum weight of 40 pounds.
- Patient able to read English and to give consent to study participation.
Key exclusion criteria (19 listed)
- Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
- Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
- Patients who received a Lyme vaccination.
- Patients with anemia defined as a serum hemoglobin <10gm/dL.
- Patients who are participating in, or plan to participate in, any investigational drug study.
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 |
|---|---|---|
| PCR based assayWhole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined. In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen). | Diagnostic test | 1a:Lyme patients- Erythema Migrans(EM)rash present, 1b:Lyme patients no typical EM, Cohort 2: healthy controls |
| Serology based assay1. The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b. 2. The Immunetics C6 Lyme ELISA assay. 3. A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines 4. A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections. Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared. | Diagnostic test | 1a:Lyme patients- Erythema Migrans(EM)rash present, 1b:Lyme patients no typical EM, Cohort 2: healthy controls |
| Tcell based assayA research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis. | Diagnostic test | 1a:Lyme patients- Erythema Migrans(EM)rash present, 1b:Lyme patients no typical EM, Cohort 2: healthy controls |
Primary outcome
Sample Data Analysis
Time frame: Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year.
The results will be used to calculate performance, including sensitivity and specificity of the tests under evaluation. The utility of these tests at different time points post initial presentation will be evaluated.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease, run by Oxford Immunotec at 60 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 18 inclusion and 19 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 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 was stopped early (reason given: Sponsor Decision). 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?
Sample Data Analysis (time frame: Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year.). 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 13 Dec 2018.