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NCT03505879 · ClinicalTrials.gov registry record
Next Generation Sequencing Detection of Lyme Disease
A clinical trial, sponsored by Stony Brook University.
- Completed
- Registry status
- 15
- Enrollment target
NCT03505879 is a clinical trial that has completed, run by Stony Brook University. The registered enrollment target is 15 participants.
The verdict
NCT03505879 has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a single blood sample, potentially improving its sensitivity compared to PCR testing, which only detects predetermined larger strands of DNA. We will test the ability of NGS to detect Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease. We will conduct an observational study of NGS testing on pediatric patients at all stages of Lyme disease. Study involvement will require a single study visit for clinical data collection and blood draw. We will enroll patients at all phases of suspected Lyme disease, collect clinically relevant information, and test for Lyme disease using Next Generation Sequencing and standard Lyme serologic testing. If the patient has multiple erythema migrans, Lyme meningitis, facial nerve palsy, arthritis, or carditis, a B. burgdorferi serum PCR will also be sent. Enrollment and Next Generation Sequencing blood draw will occur before or up to 24 hours after the first dose of antibiotics is administered. We will also study the impact of antibiotics on NGS testing by running the test 6-24 hours after antibiotics are started among a small subset of patients with a multiple erythema migrans rash. Collected data will be analyzed with basic descriptive statistics.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2020-05-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03505879
The ClinicalTrials.gov registry entry for NCT03505879 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT03505879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03505879 about?
NCT03505879 is a clinical study titled "Next Generation Sequencing Detection of Lyme Disease". Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a single blood sample, potentially improving its sensitivity compared to PCR testing, which only detects predetermined larger strands of DNA. We will test the ability of NGS to detect Borrelia burgdorferi DNA i...
What is the current status of trial NCT03505879?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2018-07-24. Estimated completion is 2020-05-31.
Who is sponsoring clinical trial NCT03505879?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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