<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422314</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-00717</org_study_id>
    <nct_id>NCT04422314</nct_id>
  </id_info>
  <brief_title>ImmuneSense Lyme Study</brief_title>
  <official_title>ImmuneSense Lyme Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adaptive Biotechnologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Adaptive Biotechnologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      ImmuneSense Lyme is a study, which is designed to better understand the immune response to&#xD;
      Lyme disease. This is critically important because the immune system may be able to tell us&#xD;
      important information about how our own bodies detect and respond to the disease that current&#xD;
      tests cannot. Data collected from this study may accelerate the development of better&#xD;
      diagnostics for Lyme disease and improve outcomes for many.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">October 29, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">893</enrollment>
  <condition>Lyme Disease</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Lyme disease testing cohort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>Endemic, asymptomatic controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <description>Non-endemic, asymptomatic controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <description>Potential cross-reactive disease states</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
    <description>Lyme disease testing cohort</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>T-Detect Lyme</intervention_name>
    <description>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.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_label>Cohort 5</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible participants include male and female participants, of any race and ethnicity, ages&#xD;
        7 and above (inclusive) at the time of enrollment. For Cohort 5 only, participants must be&#xD;
        18 years of age or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cohort 1:&#xD;
&#xD;
          -  Participants at or above the age of 7&#xD;
&#xD;
          -  Arm A: Participants with an EM rash ≥ 5 cm (confirmed by Lyme disease independent&#xD;
             expert) with or without other signs and symptoms of Lyme disease&#xD;
&#xD;
          -  Arm B: Participants who do not have an EM rash &gt;/= 5 cm (either not confirmed by a&#xD;
             Lyme disease independent expert or lacking a rash), but who have signs and symptoms&#xD;
             suggestive of Lyme disease that warrants further testing, such as, but not limited to&#xD;
             fever, myalgias, malaise, lymphadenopathy, rigors, arthralgias, peripheral and&#xD;
             radiculoneuropathy, encephalopathy, intermittent arthritis, meningitis, heart block,&#xD;
             carditis, etc&#xD;
&#xD;
        Cohort 2:&#xD;
&#xD;
        - Individuals in general good health, who reside in Lyme disease endemic regions&#xD;
&#xD;
        Cohort 3:&#xD;
&#xD;
        - Individuals in general good health, who reside in a region that is non-endemic for Lyme&#xD;
        disease&#xD;
&#xD;
        Cohort 4:&#xD;
&#xD;
        Sourced from a sample repository&#xD;
&#xD;
          -  Biorepositories with documented consent from participants for secondary use of their&#xD;
             sample by a third party&#xD;
&#xD;
          -  Confirmed, documented diagnoses for one of the following diseases:&#xD;
&#xD;
          -  Viral: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19&#xD;
&#xD;
          -  Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or&#xD;
             ehrlichiosis&#xD;
&#xD;
          -  Bacterial infection: syphilis&#xD;
&#xD;
          -  Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE),&#xD;
             Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), chronic fatigue syndrome&#xD;
&#xD;
          -  For infections, active infections are preferred and should be prioritized. Past&#xD;
             infections will be acceptable for infections that are difficult to obtain.&#xD;
&#xD;
        Prospective collection Inclusion criteria&#xD;
&#xD;
          -  Confirmed, documented diagnoses for one of the following diseases:&#xD;
&#xD;
          -  Viral: Epstein-Barr virus (EBV), cytomegalovirus (CMV), influenza, or COVID-19&#xD;
&#xD;
          -  Tick-borne diseases: babesiosis, rocky mountain spotted fever, anaplasmosis, or&#xD;
             ehrlichiosis&#xD;
&#xD;
          -  Bacterial infection: syphilis&#xD;
&#xD;
          -  Autoimmune/rheumatologic/neurologic diseases: Systemic Lupus Erythematous (SLE),&#xD;
             Rheumatoid Arthritis (RA), Multiple Sclerosis (MS), or chronic fatigue syndrome&#xD;
&#xD;
          -  For infections, active infections are preferred and should be prioritized. Past&#xD;
             infections will be acceptable for infections that are difficult to obtain.&#xD;
&#xD;
        Cohort 5:&#xD;
&#xD;
          -  Participants ages 18 and above&#xD;
&#xD;
          -  Arm A: Participants with an EM rash ≥ 5 cm (confirmed by Lyme disease independent&#xD;
             expert) with or without other signs and symptoms of Lyme disease&#xD;
&#xD;
          -  Arm B: Participants who do not have an EM rash &gt;/= 5 cm (either not confirmed by a&#xD;
             Lyme disease independent expert or lacking a rash), but who have signs and symptoms&#xD;
             suggestive of Lyme disease that warrants further testing, such as, but not limited to&#xD;
             fever, myalgias, malaise, lymphadenopathy, rigors, arthralgias, peripheral and&#xD;
             radiculoneuropathy, encephalopathy, intermittent arthritis, meningitis, heart block,&#xD;
             carditis, etc&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be excluded from the study if they meet any of the following&#xD;
             criteria:&#xD;
&#xD;
          -  Participant is a pregnant woman, prisoner, mentally disabled person, or ward-of-the&#xD;
             state.&#xD;
&#xD;
          -  Participant has any significant condition, laboratory abnormality, or psychiatric&#xD;
             illness that would prevent the participant from safely participating in the study.&#xD;
&#xD;
          -  Participant has been exposed to an investigational drug (new chemical entity) within&#xD;
             60 days prior to enrollment at the discretion of the investigator.&#xD;
&#xD;
          -  Participant has donated more than one pint or 500cc of blood in the past two months or&#xD;
             weight-based limits for pediatric populations.&#xD;
&#xD;
          -  Received the Lyme disease vaccine&#xD;
&#xD;
          -  Chronic infection with HIV, Tuberculosis, Hepatitis C, or Hepatitis B&#xD;
&#xD;
          -  Active malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Namita Singh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical Director, Clinical Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Lewiston</city>
        <state>Maine</state>
        <zip>04240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Elkridge</city>
        <state>Maryland</state>
        <zip>21075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Endwell</city>
        <state>New York</state>
        <zip>13760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Hatboro</city>
        <state>Pennsylvania</state>
        <zip>19040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Scottdale</city>
        <state>Pennsylvania</state>
        <zip>15683</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Tipton</city>
        <state>Pennsylvania</state>
        <zip>16684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Danville</city>
        <state>Virginia</state>
        <zip>24541</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Kingwood</city>
        <state>West Virginia</state>
        <zip>26537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adaptive Biotechnologies Investigational Site</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>erythema migrans rash</keyword>
  <keyword>bullseye rash</keyword>
  <keyword>early acute Lyme disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lyme Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422314
org study id: PRO-00717
nct id: NCT04422314
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
observational model: Cohort
time perspective: Prospective
measure: To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT
time frame: Baseline
description: 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.
measure: To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT
time frame: Baseline
description: 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.
arm group label: Cohort 1
description: Lyme disease testing cohort
arm group label: Cohort 2
description: Endemic, asymptomatic controls
arm group label: Cohort 3
description: Non-endemic, asymptomatic controls
arm group label: Cohort 4
description: Potential cross-reactive disease states
arm group label: Cohort 5
description: Lyme disease testing cohort
intervention type: Diagnostic Test
intervention name: T-Detect Lyme
description: 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.
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
last name: Namita Singh, MD
role: Study Director
affiliation: Medical Director, Clinical Development
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country: United States
responsible party type: Sponsor
mesh term: Lyme Disease
sharing ipd: No