Lyme Test Indication Combinations (LyTIC) Study (LyTIC)

December 11, 2018 updated by: Oxford Immunotec
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

500 subjects aged 5 years or older.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Tests at different time points post inital presentation will be evaluated through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford Immunotec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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