ImmuneSense Lyme Study

Study Overview
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Brief Summary
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ImmuneSense Lyme is a study, which is designed to better understand the immune response to Lyme disease. This is critically important because the immune system may be able to tell us important information about how our own bodies detect and respond to the disease that current tests cannot. Data collected from this study may accelerate the development of better diagnostics for Lyme disease and improve outcomes for many.

Official Title
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ImmuneSense Lyme Study

Conditions
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Lyme Disease

Intervention / Treatment
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* Diagnostic Test: T-Detect Lyme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort 1: Participants at or above the age of 7 Arm A: Participants with an EM rash ≥ 5 cm (confirmed by Lyme disease independent expert) with or without other signs and symptoms of Lyme disease Arm B: Participants who do not have an EM rash >/= 5 cm (either not confirmed by a Lyme disease independent expert or lacking a rash), but who have signs and symptoms suggestive of Lyme disease that warrants further testing, such as, but not limited to fever, myalgias, malaise, lymphadenopathy, rigors, arthralgias, peripheral and radiculoneuropathy, encephalopathy, intermittent arthritis, meningitis, heart block, carditis, etc Cohort 2: - Individuals in general good health, who reside in Lyme disease endemic regions Cohort 3: - Individuals in general good health, who reside in a region that is non-endemic for Lyme disease Cohort 4: Sourced from a sample repository Biorepositories with documented consent from participants for secondary use of their sample by a third party Confirmed, documented diagnoses for one of the following diseases: Viral: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19 Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or ehrlichiosis Bacterial infection: syphilis Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE), Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), chronic fatigue syndrome For infections, active infections are preferred and should be prioritized. Past infections will be acceptable for infections that are difficult to obtain. Prospective collection Inclusion criteria Confirmed, documented diagnoses for one of the following diseases: Viral: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19 Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or ehrlichiosis Bacterial infection: syphilis Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE), Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), or chronic fatigue syndrome For infections, active infections are preferred and should be prioritized. Past infections will be acceptable for infections that are difficult to obtain. Cohort 5: Participants ages 18 and above Arm A: Participants with an EM rash ≥ 5 cm (confirmed by Lyme disease independent expert) with or without other signs and symptoms of Lyme disease Arm B: Participants who do not have an EM rash >/= 5 cm (either not confirmed by a Lyme disease independent expert or lacking a rash), but who have signs and symptoms suggestive of Lyme disease that warrants further testing, such as, but not limited to fever, myalgias, malaise, lymphadenopathy, rigors, arthralgias, peripheral and radiculoneuropathy, encephalopathy, intermittent arthritis, meningitis, heart block, carditis, etc Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: Participant is a pregnant woman, prisoner, mentally disabled person, or ward-of-the state. Participant has any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study. Participant has been exposed to an investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the investigator. Participant has donated more than one pint or 500cc of blood in the past two months or weight-based limits for pediatric populations. Received the Lyme disease vaccine Chronic infection with HIV, Tuberculosis, Hepatitis C, or Hepatitis B Active malignancy

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Lyme disease testing cohort | Diagnostic Test: T-Detect Lyme<br>* T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.<br>|
| Cohort 2<br>Endemic, asymptomatic controls | Diagnostic Test: T-Detect Lyme<br>* T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.<br>|
| Cohort 3<br>Non-endemic, asymptomatic controls | Diagnostic Test: T-Detect Lyme<br>* T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.<br>|
| Cohort 4<br>Potential cross-reactive disease states | Diagnostic Test: T-Detect Lyme<br>* T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.<br>|
| Cohort 5<br>Lyme disease testing cohort | Diagnostic Test: T-Detect Lyme<br>* T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT | Diagnostic sensitivity is defined as the percentage of persons who have a given disorder who are identified by the assay as positive for Lyme disease. | Baseline | 
| To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT | Diagnostic specificity is defined as the percentage of persons who do not have a given condition who are identified by the assay as negative for Lyme disease. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erythema migrans rash, bullseye rash, early acute Lyme disease