ImmuneSense Lyme Study (NCT04422314) | Clinical Trial Compass
CompletedNot Applicable
ImmuneSense Lyme Study
United States893 participantsStarted 2020-07-09
Plain-language summary
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.
Who can participate
Age range7 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prefer…
What they're measuring
1
To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT
Timeframe: Baseline
2
To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT