Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

893

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2020

Geographic Reach

1 country

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

June 1, 2020

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed

1 month until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed

Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

June 1, 2020

Last Update Submit

April 13, 2022

Conditions

Lyme Disease

Keywords

erythema migrans rashbullseye rashearly acute Lyme disease

Outcome Measures

Primary Outcomes (2)

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

Study Arms (5)

Cohort 1

Lyme disease testing cohort

Diagnostic Test: T-Detect Lyme

Cohort 2

Endemic, asymptomatic controls

Diagnostic Test: T-Detect Lyme

Cohort 3

Non-endemic, asymptomatic controls

Diagnostic Test: T-Detect Lyme

Cohort 4

Potential cross-reactive disease states

Diagnostic Test: T-Detect Lyme

Cohort 5

Lyme disease testing cohort

Diagnostic Test: T-Detect Lyme

Interventions

T-Detect LymeDIAGNOSTIC_TEST

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.

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age7 Years+

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Eligible participants include male and female participants, of any race and ethnicity, ages 7 and above (inclusive) at the time of enrollment. For Cohort 5 only, participants must be 18 years of age or older.

You may qualify if:

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
+12 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.