Lyme DiseaseNCT04422314
ImmuneSense Lyme Study
An observational study of Lyme Disease, run by Adaptive Biotechnologies at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Lyme Disease
- What is being tested?
- T-Detect Lyme
- How many people
- 893 participants
- Where
- 34 sitesUnited States
- Study dates
- 9 Jul 2020to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 28Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Adaptive Biotechnologies Investigational Site
Altoona, Pennsylvania, 16601
Adaptive Biotechnologies Investigational Site
Altoona, Pennsylvania, 16801
Adaptive Biotechnologies Investigational Site
Baton Rouge, Louisiana, 70806
Adaptive Biotechnologies Investigational Site
Beverly, Massachusetts, 01915
Adaptive Biotechnologies Investigational Site
Binghamton, New York, 13901
Adaptive Biotechnologies Investigational Site
Burke, Virginia, 22015
Adaptive Biotechnologies Investigational Site
Dakota Dunes, South Dakota, 57049
Adaptive Biotechnologies Investigational Site
Danbury, Connecticut, 06810
Adaptive Biotechnologies Investigational Site
Danville, Virginia, 24541
Adaptive Biotechnologies Investigational Site
Elkridge, Maryland, 21075
Adaptive Biotechnologies Investigational Site
Endwell, New York, 13760
Adaptive Biotechnologies Investigational Site
Freehold, New Jersey, 07728
Adaptive Biotechnologies Investigational Site
Hatboro, Pennsylvania, 19040
Adaptive Biotechnologies Investigational Site
Kingwood, West Virginia, 26537
Adaptive Biotechnologies Investigational Site
Lewiston, Maine, 04240
Adaptive Biotechnologies Investigational Site
Macon, Georgia, 31210
Adaptive Biotechnologies Investigational Site
Methuen, Massachusetts, 01844
Adaptive Biotechnologies Investigational Site
Morgantown, West Virginia, 26501
Adaptive Biotechnologies Investigational Site
New Windsor, New York, 12553
Adaptive Biotechnologies Investigational Site
Norfolk, Virginia, 23502
Adaptive Biotechnologies Investigational Site
Pittsburgh, Pennsylvania, 15236
Adaptive Biotechnologies Investigational Site
Pittsburgh, Pennsylvania, 15243
Adaptive Biotechnologies Investigational Site
Rapid City, South Dakota, 57702
Adaptive Biotechnologies Investigational Site
Rockville, Maryland, 20854
Adaptive Biotechnologies Investigational Site
Savannah, Georgia, 31406
Adaptive Biotechnologies Investigational Site
Scottdale, Pennsylvania, 15683
Adaptive Biotechnologies Investigational Site
Smithfield, Pennsylvania, 15478
Adaptive Biotechnologies Investigational Site
Springfield, Massachusetts, 01101
Adaptive Biotechnologies Investigational Site
Syracuse, New York, 13210
Adaptive Biotechnologies Investigational Site
Tipton, Pennsylvania, 16684
Adaptive Biotechnologies Investigational Site
Towson, Maryland, 21204
Adaptive Biotechnologies Investigational Site
Uniontown, Pennsylvania, 15401
Adaptive Biotechnologies Investigational Site
Warwick, Rhode Island, 02886
Adaptive Biotechnologies Investigational Site
Wauwatosa, Wisconsin, 53226
About this study
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.
- Conditions
- Lyme Disease
- Being tested
- T-Detect Lyme
- Keywords
- erythema migrans rash, bullseye rash, early acute Lyme disease
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Detect LymeDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 | Lyme disease testing cohort Receives: Diagnostic Test: T-Detect Lyme | |
| Cohort 2 | Endemic, asymptomatic controls Receives: Diagnostic Test: T-Detect Lyme | |
| Cohort 3 | Non-endemic, asymptomatic controls Receives: Diagnostic Test: T-Detect Lyme | |
| Cohort 4 | Potential cross-reactive disease states Receives: Diagnostic Test: T-Detect Lyme | |
| Cohort 5 | Lyme disease testing cohort Receives: Diagnostic Test: T-Detect Lyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT
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.
Measured: Baseline
To demonstrate Specificity of T-Detect Lyme Assay relative to STTT and MTTT
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start9 Jul 2020
- Primary completion29 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Namita Singh, MD, Study director, Medical Director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422314
- Sponsor's protocol ID
- PRO-00717
- Status last verified
- Apr 2022
- First submitted
- 1 Jun 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneSense Lyme Study
- ClinicalTrials.gov ID
- NCT04422314
- Acronym / sponsor ID
- PRO-00717
- Conditions
- Lyme Disease
- Keywords
- erythema migrans rash, bullseye rash, early acute Lyme disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: T-Detect LymeLyme disease testing cohort |
| Cohort 2 | – | Diagnostic Test: T-Detect LymeEndemic, asymptomatic controls |
| Cohort 3 | – | Diagnostic Test: T-Detect LymeNon-endemic, asymptomatic controls |
| Cohort 4 | – | Diagnostic Test: T-Detect LymePotential cross-reactive disease states |
| Cohort 5 | – | Diagnostic Test: T-Detect LymeLyme disease testing cohort |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (28 listed)
- 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
- Individuals in general good health, who reside in Lyme disease endemic regions
- Individuals in general good health, who reside in a region that is non-endemic for Lyme disease
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Detect LymeT-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. | Diagnostic test | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namita Singh, MD study director
Medical Director, Clinical Development
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease, run by Adaptive Biotechnologies at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate sensitivity of T-Detect Lyme Assay relative to STTT and MTTT (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.