Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
893 participants
OBSERVATIONAL
2020-07-09
2021-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Lyme disease testing cohort
T-Detect Lyme
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 2
Endemic, asymptomatic controls
T-Detect Lyme
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 3
Non-endemic, asymptomatic controls
T-Detect Lyme
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 4
Potential cross-reactive disease states
T-Detect Lyme
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 5
Lyme disease testing cohort
T-Detect Lyme
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.
Interventions
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T-Detect Lyme
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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
7 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Adaptive Biotechnologies
INDUSTRY
Responsible Party
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Principal Investigators
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Namita Singh, MD
Role: STUDY_DIRECTOR
Medical Director, Clinical Development
Locations
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Adaptive Biotechnologies Investigational Site
Danbury, Connecticut, United States
Adaptive Biotechnologies Investigational Site
Macon, Georgia, United States
Adaptive Biotechnologies Investigational Site
Savannah, Georgia, United States
Adaptive Biotechnologies Investigational Site
Baton Rouge, Louisiana, United States
Adaptive Biotechnologies Investigational Site
Lewiston, Maine, United States
Adaptive Biotechnologies Investigational Site
Elkridge, Maryland, United States
Adaptive Biotechnologies Investigational Site
Rockville, Maryland, United States
Adaptive Biotechnologies Investigational Site
Towson, Maryland, United States
Adaptive Biotechnologies Investigational Site
Beverly, Massachusetts, United States
Adaptive Biotechnologies Investigational Site
Methuen, Massachusetts, United States
Adaptive Biotechnologies Investigational Site
Springfield, Massachusetts, United States
Adaptive Biotechnologies Investigational Site
Freehold, New Jersey, United States
Adaptive Biotechnologies Investigational Site
Binghamton, New York, United States
Adaptive Biotechnologies Investigational Site
Endwell, New York, United States
Adaptive Biotechnologies Investigational Site
New Windsor, New York, United States
Adaptive Biotechnologies Investigational Site
Syracuse, New York, United States
Adaptive Biotechnologies Investigational Site
Altoona, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Altoona, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Hatboro, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Pittsburgh, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Pittsburgh, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Scottdale, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Smithfield, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Tipton, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Uniontown, Pennsylvania, United States
Adaptive Biotechnologies Investigational Site
Warwick, Rhode Island, United States
Adaptive Biotechnologies Investigational Site
Dakota Dunes, South Dakota, United States
Adaptive Biotechnologies Investigational Site
Rapid City, South Dakota, United States
Adaptive Biotechnologies Investigational Site
Burke, Virginia, United States
Adaptive Biotechnologies Investigational Site
Danville, Virginia, United States
Adaptive Biotechnologies Investigational Site
Norfolk, Virginia, United States
Adaptive Biotechnologies Investigational Site
Kingwood, West Virginia, United States
Adaptive Biotechnologies Investigational Site
Morgantown, West Virginia, United States
Adaptive Biotechnologies Investigational Site
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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PRO-00717
Identifier Type: -
Identifier Source: org_study_id
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