Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04422314 · ClinicalTrials.gov registry record
ImmuneSense Lyme Study
A clinical trial of Lyme Disease, sponsored by Adaptive Biotechnologies.
- Completed
- Registry status
- 893
- Enrollment target
- 20
- Study locations
NCT04422314: Completed study of Lyme Disease, sponsored by Adaptive Biotechnologies.
NCT04422314 is a study of Lyme Disease that has completed, run by Adaptive Biotechnologies. The registered enrollment target is 893 participants, below the 3,775-participant average among 9 other Lyme Disease trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04422314, a study of Lyme Disease, has completed, sponsored by Adaptive Biotechnologies.
- COMPLETED
- Registry status
- 893 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST T-Detect Lyme
Study Locations (20)
New York
- Adaptive Biotechnologies Investigational Site - Binghamton
- Adaptive Biotechnologies Investigational Site - Endwell
- Adaptive Biotechnologies Investigational Site - New Windsor
- Adaptive Biotechnologies Investigational Site - Syracuse
Pennsylvania
- Adaptive Biotechnologies Investigational Site - Altoona
- Adaptive Biotechnologies Investigational Site - Altoona
- Adaptive Biotechnologies Investigational Site - Hatboro
- Adaptive Biotechnologies Investigational Site - Pittsburgh
Maryland
- Adaptive Biotechnologies Investigational Site - Elkridge
- Adaptive Biotechnologies Investigational Site - Rockville
- Adaptive Biotechnologies Investigational Site - Towson
Massachusetts
- Adaptive Biotechnologies Investigational Site - Beverly
- Adaptive Biotechnologies Investigational Site - Methuen
- Adaptive Biotechnologies Investigational Site - Springfield
Georgia
- Adaptive Biotechnologies Investigational Site - Macon
- Adaptive Biotechnologies Investigational Site - Savannah
Connecticut
- Adaptive Biotechnologies Investigational Site - Danbury
Louisiana
- Adaptive Biotechnologies Investigational Site - Baton Rouge
Maine
- Adaptive Biotechnologies Investigational Site - Lewiston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 893 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2021-10-30 |
What the finished NCT04422314 record still lists
NCT04422314 is an observational study that tracks outcomes without assigning an intervention. The registered 893 participants enrollment target is mid-sized for trials with a published cap, below the 3,775-participant average among 9 other Lyme Disease trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Lyme Disease appearing as the primary indexed condition, and to 1 intervention - of which T-Detect Lyme is the first listed.
NCT04422314 names 20 study sites across 9 states, led by New York, Pennsylvania, Maryland.
Frequently Asked Questions
What is clinical trial NCT04422314 about?
NCT04422314 is a clinical study titled "ImmuneSense Lyme 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 coll...
What is the current status of trial NCT04422314?
This trial is currently completed. The enrollment target is 893 participants. The study started on 2020-07-09. Estimated completion is 2021-10-30.
What conditions does trial NCT04422314 study?
This clinical trial studies the following conditions: Lyme Disease.
What interventions are being tested in trial NCT04422314?
The interventions under investigation include: T-Detect Lyme (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04422314?
This trial is sponsored by Adaptive Biotechnologies, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04422314 being conducted?
This trial has 20 study locations across Connecticut, Georgia, Louisiana, Maine, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lyme Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04422314's enrollment target sits among peer trials
893 3rd of 9 higher than 7 of 9 other Lyme Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lyme Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Human Immune Response to Ixodes Scapularis Tick Bites
RECRUITING · Phase 1
-
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure
RECRUITING
-
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
RECRUITING
-
Navigating Pregnancy and Parenthood With Lyme Disease
RECRUITING
-
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
RECRUITING
-
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05855200 · 892 participants · Phase 3
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
- NCT04862663 · 895 participants · Phase 3
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
- NCT03564340 · 890 participants · Phase 1
Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
- NCT02352116 · 900 participants · NA
Evaluation of Post-PACU Pain Management in Pediatric Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI