ImmuneSense Lyme Study

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    990
  • sponsor
    Adaptive Biotechnologies
Updated on 27 November 2020
Investigator
Sarah Duffy
Primary Contact
Adaptive Biotechnologies Investigational Site (7.6 mi away) Contact
+28 other location
fever
fatigue
myalgia
meningitis
PCR test
arthritis
arthralgia
rash
syphilis
tick-borne diseases

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. De-identified data collected from this study may accelerate the development of better diagnostics for Lyme disease and improve outcomes for many.

Details
Treatment immunoSEQ Dx
Clinical Study IdentifierNCT04422314
SponsorAdaptive Biotechnologies
Last Modified on27 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 7 yrs?
Gender: Male or Female
Do you have any of these conditions: Lyme Disease or Lyme Disease Vaccine?
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
Documented diagnoses include diagnosis from an electronic health record or equivalent and based on an assessment by a physician utilizing clinical findings, laboratory testing, and imaging results. This will be consistent with the standard of care methods for diagnosing a given disease
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
Documented diagnoses include diagnosis from an electronic health record or equivalent and based on an assessment by a physician utilizing clinical findings, laboratory testing, and imaging results. This will be consistent with the standard of care methods for diagnosing a given disease
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
Clear my responses

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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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