Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
410 participants
OBSERVATIONAL
2017-06-08
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
PCR based assay
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 assay
1. 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.
Tcell based assay
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.
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
PCR based assay
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 assay
1. 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.
Tcell based assay
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.
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.
PCR based assay
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 assay
1. 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.
Tcell based assay
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.
Interventions
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PCR based assay
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 assay
1. 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.
Tcell based assay
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.
Eligibility Criteria
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Inclusion Criteria
Inclusion
1. Documented new onset Lyme disease EM rash (single or multiple) with photographic evidence provided to Oxford Immunotec.
2. Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
3. Patients 5 years of age or older, with a minimum weight of 40 pounds.
4. Patient able to read English and to give consent to study participation.
5. If patient is younger than 18 years of age a legally authorized representative must provide consent.
Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
Inclusion
1. 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).
2. 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.
3. Patient must be able to provide blood sample at the initial visit (prior to treatment initiation) and subsequent samples according to the schedule.
4. Patients 5 years of age or older, with a minimum weight of 40 pounds.
5. Patient able to read English and to give consent to study participation.
6. If patient is younger than 18 years of age a legally authorized representative must provide consent.
Cohort 2 (Healthy subjects):
Inclusion
1. Subjects 5 years of age or older, with a minimum weight of 40 pounds.
2. Subjects never diagnosed with any tick borne disease including Lyme disease
3. Subjects able to read English and to give consent to study participation.
4. If subject is younger than 18 years of age a legally authorized representative must provide consent.
Exclusion Criteria
1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
2. Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
3. Patients who received a Lyme vaccination.
4. Patients with anemia defined as a serum hemoglobin \<10gm/dL.
5. Patients who are participating in, or plan to participate in, any investigational drug study.
6. Patients who are considered unsuitable for the study by the Investigator.
Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
1. Patients with Lyme-like symptoms lasting longer than 1 month prior to study enrolment.
2. Patients receiving treatment for any tick borne disease (including Lyme disease) prior to enrolment.
3. Patients who received a Lyme vaccination.
4. Patients with anemia defined as a serum hemoglobin \<10gm/dL.
5. Patients who are participating in, or plan to participate in, any investigational drug study.
6. Patients who are considered unsuitable for the study by the Investigator.
Cohort 2 (Healthy subjects):
Exclusion
1. Subjects with a history of tick bite
2. Subjects with past or current tick borne disease diagnosis
3. Subjects at risk for tick borne diseases including Lyme disease
4. 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.
5. 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.
5 Years
ALL
Yes
Sponsors
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Oxford Immunotec
INDUSTRY
Responsible Party
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Locations
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Paradigm Clinical Research
Redding, California, United States
Coastal Connecticut Research
New London, Connecticut, United States
Circle CARE Center
Norwalk, Connecticut, United States
Orthopaedic Foundation for Active Lifestyles, Inc
Stamford, Connecticut, United States
Delaware Integrated Medicine
Georgetown, Delaware, United States
Eastern Research, Inc.
Hialeah, Florida, United States
South Florida Clinical Trials SFCT, A member of the Alliance, Inc.
Hialeah, Florida, United States
South Coast Research Center
Miami, Florida, United States
Advance Clinical Research
Meridian, Idaho, United States
Acadia Clinical Research
Bangor, Maine, United States
Integrative Health Center of Maine
Portland, Maine, United States
Centennial Medical Group
Eldridge, Maryland, United States
Klein & Associates, MD, PA
Hagerstown, Maryland, United States
MD Medical Research, Inc.
Oxon Hill, Maryland, United States
Rockville Internal Medicine Group
Rockville, Maryland, United States
NECCR Primacare Research,LLC
Fall River, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Metromedic Walk In
New Bedford, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
NECCR Primacare Research, LLC
Westford, Massachusetts, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Asthma and Allergy Institute of MI
Clinton Township, Michigan, United States
Oakland Medical Research
Troy, Michigan, United States
Pinnacle Research
Sartell, Minnesota, United States
Andrea Gaito
Basking Ridge, New Jersey, United States
MAffiliated Medical Associates
Florham Park, New Jersey, United States
Modern Medical
Brooklyn, New York, United States
Private Practice-Johnathan Liebowitz
Brooklyn, New York, United States
NY Arthritis Clinic
Brooklyn, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Private Practice-David Wurwitz
Flushing, New York, United States
Adirondack Medical Research Center
Glens Falls, New York, United States
NYCT, A member of Alliance, Inc.
New York, New York, United States
Mid Hudson Medical Research
Newburgh, New York, United States
John T. Mather Hospital
Port Jefferson, New York, United States
Rapid Medical Research
Cleveland, Ohio, United States
Buckeye Health and Research
Columbus, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Bally Medical Group
Barto, Pennsylvania, United States
Boyertown Medical Assoc.
Boyertown, Pennsylvania, United States
Collegeville Family Practice
Collegeville, Pennsylvania, United States
Brandywine Clinic
Downingtown, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Pediatric Medical Associates of NTN/ABG
East Norriton, Pennsylvania, United States
Liberty Family Practice/Square 1
Erie, Pennsylvania, United States
Detweiler Family Practice
Lansdale, Pennsylvania, United States
Green and Seidner Family Practice
Lansdale, Pennsylvania, United States
Suburban Research Assoc.
Media, Pennsylvania, United States
Brookside Family Practice and Pediatrics
Pottstown, Pennsylvania, United States
Spring-Ford Family Practice
Royersford, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Ocean State Clinical Research
Lincoln, Rhode Island, United States
NECCR Primacare Research, LLC
Portsmouth, Rhode Island, United States
Atascosa Clinical Trial
Lytle, Texas, United States
Brookside Family Health Care
Hinesburg, Vermont, United States
Millennium Clincial Trials
Arlington, Virginia, United States
Burke Internal Medicine
Burke, Virginia, United States
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Exemplar Research
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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L3
Identifier Type: -
Identifier Source: org_study_id