Lyme Test Indication Combinations (LyTIC) Study
- Conditions
- Lyme Disease
- Interventions
- Diagnostic Test: PCR based assayDiagnostic Test: Serology based assayDiagnostic Test: Tcell based assay
- Registration Number
- NCT03201042
- Lead Sponsor
- Oxford Immunotec
- Brief Summary
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 410
- Cohort 1a (typical EM and intention to treat):
Inclusion
- 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.
Cohort 1b (no typical EM; Lyme disease symptoms; intention to treat):
Inclusion
- 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):
Inclusion
- 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.
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Exclusion Cohort 1a (typical EM and 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 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):
Exclusion
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1a:Lyme patients- Erythema Migrans(EM)rash present PCR based assay Patients with newly diagnosed Lyme disease based on the presence of a physician-documented EM rash. PCR, serology and Tcell based assay. 1a:Lyme patients- Erythema Migrans(EM)rash present Serology based assay Patients 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 Serology based assay 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 Cohort 2: healthy controls PCR based assay 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. 1a:Lyme patients- Erythema Migrans(EM)rash present Tcell based assay Patients 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 PCR based assay 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 1b:Lyme patients no typical EM Tcell based assay 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 Cohort 2: healthy controls Serology based assay 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. Cohort 2: healthy controls Tcell based assay 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.
- Primary Outcome Measures
Name Time Method Sample Data Analysis 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (59)
Circle CARE Center
🇺🇸Norwalk, Connecticut, United States
Collegeville Family Practice
🇺🇸Collegeville, Pennsylvania, United States
Acadia Clinical Research
🇺🇸Bangor, Maine, United States
Klein & Associates, MD, PA
🇺🇸Hagerstown, Maryland, United States
MD Medical Research, Inc.
🇺🇸Oxon Hill, Maryland, United States
NECCR Primacare Research,LLC
🇺🇸Fall River, Massachusetts, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Centennial Medical Group
🇺🇸Eldridge, Maryland, United States
Orthopaedic Foundation for Active Lifestyles, Inc
🇺🇸Stamford, Connecticut, United States
Metromedic Walk In
🇺🇸New Bedford, Massachusetts, United States
Coastal Connecticut Research
🇺🇸New London, Connecticut, United States
Advance Clinical Research
🇺🇸Meridian, Idaho, United States
Private Practice-Johnathan Liebowitz
🇺🇸Brooklyn, New York, United States
NY Arthritis Clinic
🇺🇸Brooklyn, New York, United States
Asthma and Allergy Institute of MI
🇺🇸Clinton Township, Michigan, United States
Brandywine Clinic
🇺🇸Downingtown, Pennsylvania, United States
Integrative Health Center of Maine
🇺🇸Portland, Maine, United States
Rockville Internal Medicine Group
🇺🇸Rockville, Maryland, United States
Delaware Integrated Medicine
🇺🇸Georgetown, Delaware, United States
Andrea Gaito
🇺🇸Basking Ridge, New Jersey, United States
Paradigm Clinical Research
🇺🇸Redding, California, United States
Pinnacle Research
🇺🇸Sartell, Minnesota, United States
Brookside Family Health Care
🇺🇸Hinesburg, Vermont, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
South Florida Clinical Trials SFCT, A member of the Alliance, Inc.
🇺🇸Hialeah, Florida, United States
Pediatric Medical Associates of NTN/ABG
🇺🇸East Norriton, Pennsylvania, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Modern Medical
🇺🇸Brooklyn, New York, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
NECCR Primacare Research, LLC
🇺🇸Portsmouth, Rhode Island, United States
John T. Mather Hospital
🇺🇸Port Jefferson, New York, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Adirondack Medical Research Center
🇺🇸Glens Falls, New York, United States
Detweiler Family Practice
🇺🇸Lansdale, Pennsylvania, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Private Practice-David Wurwitz
🇺🇸Flushing, New York, United States
NYCT, A member of Alliance, Inc.
🇺🇸New York, New York, United States
Buckeye Health and Research
🇺🇸Columbus, Ohio, United States
Bally Medical Group
🇺🇸Barto, Pennsylvania, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
MAffiliated Medical Associates
🇺🇸Florham Park, New Jersey, United States
Toledo Institute of Clinical Research
🇺🇸Toledo, Ohio, United States
Liberty Family Practice/Square 1
🇺🇸Erie, Pennsylvania, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Suburban Research Assoc.
🇺🇸Media, Pennsylvania, United States
Boyertown Medical Assoc.
🇺🇸Boyertown, Pennsylvania, United States
Spring-Ford Family Practice
🇺🇸Royersford, Pennsylvania, United States
Atascosa Clinical Trial
🇺🇸Lytle, Texas, United States
Burke Internal Medicine
🇺🇸Burke, Virginia, United States
Exemplar Research
🇺🇸Morgantown, West Virginia, United States
Mid Hudson Medical Research
🇺🇸Newburgh, New York, United States
Green and Seidner Family Practice
🇺🇸Lansdale, Pennsylvania, United States
Brookside Family Practice and Pediatrics
🇺🇸Pottstown, Pennsylvania, United States
Millennium Clincial Trials
🇺🇸Arlington, Virginia, United States
The Education and Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
Ocean State Clinical Research
🇺🇸Lincoln, Rhode Island, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
South Coast Research Center
🇺🇸Miami, Florida, United States