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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422314
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 19, 2020
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. De-identified 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: immunoSEQ Dx

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Study Type : Observational
Estimated Enrollment : 990 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ImmuneSense Lyme Study
Estimated Study Start Date : June 25, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 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: immunoSEQ Dx
immunoSEQ Dx 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: immunoSEQ Dx
immunoSEQ Dx 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: immunoSEQ Dx
immunoSEQ Dx 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: immunoSEQ Dx
immunoSEQ Dx 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 for AV/Development studies
Diagnostic Test: immunoSEQ Dx
immunoSEQ Dx 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 demonstrate Sensitivity of immunoSEQ Dx Lyme Assay is superior to STTT [ 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 immunoSEQ Dx Lyme Assay is noninferior to STTT [ 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.


Secondary Outcome Measures :
  1. To demonstrate ability of immunoSEQ Dx Lyme Assay to detect Lyme disease over the time [ Time Frame: Base line, 30 days, 6 months, 12 months ]
    To demonstrate ability of immunoSEQ Dx Lyme Assay to detect Lyme disease over the time at base line, 1 months, 6 months, and 12 months



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
  • 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

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


Contacts
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Contact: Jennifer Dines, MD 12062792486 ext 12062792486 jdines@adaptivebiotech.com
Contact: Emily Svejnoha, Ms. 12066932032 ext 12066932032 esvejnoha@adaptivebiotech.com

Sponsors and Collaborators
Adaptive Biotechnologies
Iqvia Pty Ltd
Investigators
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Study Director: Thomas Manley, MD VP, 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: June 19, 2020
Last Verified: June 2020
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
Additional relevant MeSH terms:
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Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections