ImmuneSense Lyme Study

April 13, 2022 updated by: Adaptive Biotechnologies
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
893

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Adaptive Biotechnologies Investigational Site
    • Georgia
      • Macon, Georgia, United States, 31210
        • Adaptive Biotechnologies Investigational Site
      • Savannah, Georgia, United States, 31406
        • Adaptive Biotechnologies Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Adaptive Biotechnologies Investigational Site
    • Maine
      • Lewiston, Maine, United States, 04240
        • Adaptive Biotechnologies Investigational Site
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Adaptive Biotechnologies Investigational Site
      • Rockville, Maryland, United States, 20854
        • Adaptive Biotechnologies Investigational Site
      • Towson, Maryland, United States, 21204
        • Adaptive Biotechnologies Investigational Site
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Adaptive Biotechnologies Investigational Site
      • Methuen, Massachusetts, United States, 01844
        • Adaptive Biotechnologies Investigational Site
      • Springfield, Massachusetts, United States, 01101
        • Adaptive Biotechnologies Investigational Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Adaptive Biotechnologies Investigational Site
    • New York
      • 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
        • Adaptive Biotechnologies Investigational Site
    • Pennsylvania
      • 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
        • Adaptive Biotechnologies Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Adaptive Biotechnologies Investigational Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Adaptive Biotechnologies Investigational Site
      • Rapid City, South Dakota, United States, 57702
        • Adaptive Biotechnologies Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • Adaptive Biotechnologies Investigational Site
      • Danville, Virginia, United States, 24541
        • Adaptive Biotechnologies Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Adaptive Biotechnologies Investigational Site
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Adaptive Biotechnologies Investigational Site
      • Morgantown, West Virginia, United States, 26501
        • Adaptive Biotechnologies Investigational Site
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Adaptive Biotechnologies Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adaptive Biotechnologies

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-00717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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