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ImmuneSense Lyme Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422314
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : April 15, 2022
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Adaptive Biotechnologies

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.

Condition or disease Intervention/treatment
Lyme Disease Diagnostic Test: T-Detect Lyme

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Study Type : Observational
Actual Enrollment : 893 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ImmuneSense Lyme Study
Actual Study Start Date : July 9, 2020
Actual Primary Completion Date : October 29, 2021
Actual Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Group/Cohort Intervention/treatment
Cohort 1
Lyme disease testing cohort
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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
Diagnostic Test: 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.




Primary Outcome Measures :
  1. To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT [ Time Frame: Baseline ]
    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.

  2. To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422314


Locations
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United States, Connecticut
Adaptive Biotechnologies Investigational Site
Danbury, Connecticut, United States, 06810
United States, Georgia
Adaptive Biotechnologies Investigational Site
Macon, Georgia, United States, 31210
Adaptive Biotechnologies Investigational Site
Savannah, Georgia, United States, 31406
United States, Louisiana
Adaptive Biotechnologies Investigational Site
Baton Rouge, Louisiana, United States, 70806
United States, Maine
Adaptive Biotechnologies Investigational Site
Lewiston, Maine, United States, 04240
United States, Maryland
Adaptive Biotechnologies Investigational Site
Elkridge, Maryland, United States, 21075
Adaptive Biotechnologies Investigational Site
Rockville, Maryland, United States, 20854
Adaptive Biotechnologies Investigational Site
Towson, Maryland, United States, 21204
United States, Massachusetts
Adaptive Biotechnologies Investigational Site
Beverly, Massachusetts, United States, 01915
Adaptive Biotechnologies Investigational Site
Methuen, Massachusetts, United States, 01844
Adaptive Biotechnologies Investigational Site
Springfield, Massachusetts, United States, 01101
United States, New Jersey
Adaptive Biotechnologies Investigational Site
Freehold, New Jersey, United States, 07728
United States, New York
Adaptive Biotechnologies Investigational Site
Binghamton, New York, United States, 13901
Adaptive Biotechnologies Investigational Site
Endwell, New York, United States, 13760
Adaptive Biotechnologies Investigational Site
New Windsor, New York, United States, 12553
Adaptive Biotechnologies Investigational Site
Syracuse, New York, United States, 13210
United States, Pennsylvania
Adaptive Biotechnologies Investigational Site
Altoona, Pennsylvania, United States, 16601
Adaptive Biotechnologies Investigational Site
Altoona, Pennsylvania, United States, 16801
Adaptive Biotechnologies Investigational Site
Hatboro, Pennsylvania, United States, 19040
Adaptive Biotechnologies Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Adaptive Biotechnologies Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
Adaptive Biotechnologies Investigational Site
Scottdale, Pennsylvania, United States, 15683
Adaptive Biotechnologies Investigational Site
Smithfield, Pennsylvania, United States, 15478
Adaptive Biotechnologies Investigational Site
Tipton, Pennsylvania, United States, 16684
Adaptive Biotechnologies Investigational Site
Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
Adaptive Biotechnologies Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Dakota
Adaptive Biotechnologies Investigational Site
Dakota Dunes, South Dakota, United States, 57049
Adaptive Biotechnologies Investigational Site
Rapid City, South Dakota, United States, 57702
United States, Virginia
Adaptive Biotechnologies Investigational Site
Burke, Virginia, United States, 22015
Adaptive Biotechnologies Investigational Site
Danville, Virginia, United States, 24541
Adaptive Biotechnologies Investigational Site
Norfolk, Virginia, United States, 23502
United States, West Virginia
Adaptive Biotechnologies Investigational Site
Kingwood, West Virginia, United States, 26537
Adaptive Biotechnologies Investigational Site
Morgantown, West Virginia, United States, 26501
United States, Wisconsin
Adaptive Biotechnologies Investigational Site
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Adaptive Biotechnologies
Iqvia Pty Ltd
Investigators
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Study Director: Namita Singh, MD Medical Director, Clinical Development
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Responsible Party: Adaptive Biotechnologies
ClinicalTrials.gov Identifier: NCT04422314    
Other Study ID Numbers: PRO-00717
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Adaptive Biotechnologies:
erythema migrans rash
bullseye rash
early acute Lyme disease
Additional relevant MeSH terms:
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Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Borrelia Infections
Spirochaetales Infections
Tick-Borne Diseases
Vector Borne Diseases