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ImmuneSense Lyme Study

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ClinicalTrials.gov Identifier: NCT04422314
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Adaptive Biotechnologies

Tracking Information
First Submitted Date June 1, 2020
First Posted Date June 9, 2020
Last Update Posted Date April 12, 2021
Actual Study Start Date July 9, 2020
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: June 5, 2020)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 5, 2020)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ImmuneSense Lyme Study
Official Title ImmuneSense Lyme Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Lyme Disease
Intervention 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.
Study Groups/Cohorts
  • Cohort 1
    Lyme disease testing cohort
    Intervention: Diagnostic Test: T-Detect Lyme
  • Cohort 2
    Endemic, asymptomatic controls
    Intervention: Diagnostic Test: T-Detect Lyme
  • Cohort 3
    Non-endemic, asymptomatic controls
    Intervention: Diagnostic Test: T-Detect Lyme
  • Cohort 4
    Potential cross-reactive disease states
    Intervention: Diagnostic Test: T-Detect Lyme
  • Cohort 5
    Lyme disease testing cohort
    Intervention: Diagnostic Test: T-Detect Lyme
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2020)
990
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sarah Duffy 2066006762 sduffy@adaptivebiotech.com
Contact: Jia Qadeer 2066006761 jqadeer@adaptivebiotech.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04422314
Other Study ID Numbers PRO-00717
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Adaptive Biotechnologies
Study Sponsor Adaptive Biotechnologies
Collaborators Iqvia Pty Ltd
Investigators
Study Director: Thomas Manley, MD VP, Clinical Development
Principal Investigator: Jennifer Dines, MD Sr. Medical Director, Clinical Development
PRS Account Adaptive Biotechnologies
Verification Date April 2021