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Lyme Test Indication Combinations (LyTIC) Study (LyTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201042
Recruitment Status : Terminated (Sponsor Decision)
First Posted : June 28, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Oxford Immunotec

Brief Summary:
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis

Condition or disease Intervention/treatment
Lyme Disease Diagnostic Test: PCR based assay Diagnostic Test: Serology based assay Diagnostic Test: Tcell based assay

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.

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Study Type : Observational
Actual Enrollment : 410 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lyme Test Indication Combinations (LyTIC) Study
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Group/Cohort Intervention/treatment
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.
Diagnostic Test: 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).


Diagnostic Test: 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.


Diagnostic Test: 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
Diagnostic Test: 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).


Diagnostic Test: 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.


Diagnostic Test: 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.
Diagnostic Test: 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).


Diagnostic Test: 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.


Diagnostic Test: 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.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
whole blood serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
500 subjects aged 5 years or older.
Criteria

Inclusion Criteria:

  • Cohort 1a (typical EM and intention to treat):

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:

  • Exclusion Cohort 1a (typical EM and 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201042


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Locations
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United States, California
Paradigm Clinical Research
Redding, California, United States, 96001
United States, Connecticut
Coastal Connecticut Research
New London, Connecticut, United States, 06320
Circle CARE Center
Norwalk, Connecticut, United States, 06850
Orthopaedic Foundation for Active Lifestyles, Inc
Stamford, Connecticut, United States, 06905
United States, Delaware
Delaware Integrated Medicine
Georgetown, Delaware, United States, 19958
United States, Florida
Eastern Research, Inc.
Hialeah, Florida, United States, 33013
South Florida Clinical Trials SFCT, A member of the Alliance, Inc.
Hialeah, Florida, United States, 33016
South Coast Research Center
Miami, Florida, United States, 33136
United States, Idaho
Advance Clinical Research
Meridian, Idaho, United States, 83642
United States, Maine
Acadia Clinical Research
Bangor, Maine, United States, 04401
Integrative Health Center of Maine
Portland, Maine, United States, 01430
United States, Maryland
Centennial Medical Group
Eldridge, Maryland, United States, 21075
Klein & Associates, MD, PA
Hagerstown, Maryland, United States, 21740
MD Medical Research, Inc.
Oxon Hill, Maryland, United States, 20745
Rockville Internal Medicine Group
Rockville, Maryland, United States, 20854
United States, Massachusetts
NECCR Primacare Research,LLC
Fall River, Massachusetts, United States, 02721
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Metromedic Walk In
New Bedford, Massachusetts, United States, 02740
The Research Institute
Springfield, Massachusetts, United States, 01105
NECCR Primacare Research, LLC
Westford, Massachusetts, United States, 02790
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Michigan
Asthma and Allergy Institute of MI
Clinton Township, Michigan, United States, 48038
Oakland Medical Research
Troy, Michigan, United States, 48085
United States, Minnesota
Pinnacle Research
Sartell, Minnesota, United States, 56377
United States, New Jersey
Andrea Gaito
Basking Ridge, New Jersey, United States, 07920
MAffiliated Medical Associates
Florham Park, New Jersey, United States, 07932
United States, New York
Modern Medical
Brooklyn, New York, United States, 11207
Private Practice-Johnathan Liebowitz
Brooklyn, New York, United States, 11219
NY Arthritis Clinic
Brooklyn, New York, United States, 12298
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Private Practice-David Wurwitz
Flushing, New York, United States, 11367
Adirondack Medical Research Center
Glens Falls, New York, United States, 12801
NYCT, A member of Alliance, Inc.
New York, New York, United States, 10022
Mid Hudson Medical Research
Newburgh, New York, United States, 12550
John T. Mather Hospital
Port Jefferson, New York, United States, 11777
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
Buckeye Health and Research
Columbus, Ohio, United States, 43207
Toledo Institute of Clinical Research
Toledo, Ohio, United States, 43207
United States, Pennsylvania
Bally Medical Group
Barto, Pennsylvania, United States, 19504
Boyertown Medical Assoc.
Boyertown, Pennsylvania, United States, 18512
Collegeville Family Practice
Collegeville, Pennsylvania, United States, 19426
Brandywine Clinic
Downingtown, Pennsylvania, United States, 19335
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Pediatric Medical Associates of NTN/ABG
East Norriton, Pennsylvania, United States, 19401
Liberty Family Practice/Square 1
Erie, Pennsylvania, United States, 16506
Detweiler Family Practice
Lansdale, Pennsylvania, United States, 19446
Green and Seidner Family Practice
Lansdale, Pennsylvania, United States, 19446
Suburban Research Assoc.
Media, Pennsylvania, United States, 19063
Brookside Family Practice and Pediatrics
Pottstown, Pennsylvania, United States, 19465
Spring-Ford Family Practice
Royersford, Pennsylvania, United States, 19468
United States, Rhode Island
Safe Harbor Clinical Research
East Providence, Rhode Island, United States, 02914
Ocean State Clinical Research
Lincoln, Rhode Island, United States, 02865
NECCR Primacare Research, LLC
Portsmouth, Rhode Island, United States, 02871
United States, Texas
Atascosa Clinical Trial
Lytle, Texas, United States, 78052
United States, Vermont
Brookside Family Health Care
Hinesburg, Vermont, United States, 05461
United States, Virginia
Millennium Clincial Trials
Arlington, Virginia, United States, 22207
Burke Internal Medicine
Burke, Virginia, United States, 22015
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Manassas Clinical Research Center
Manassas, Virginia, United States, 21010
United States, West Virginia
Exemplar Research
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Oxford Immunotec

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Responsible Party: Oxford Immunotec
ClinicalTrials.gov Identifier: NCT03201042     History of Changes
Other Study ID Numbers: L3
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections