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| Name | Class |
|---|---|
| Karius, Inc. | INDUSTRY |
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The majority of children and adolescents diagnosed with cancer will experience one or more episodes of fever or infection during their course of therapy. The most common microbiologically documented infection is bloodstream infection (BSI), which can be associated with severe sepsis or death. Current methods of diagnosis require a significant load of live bacteria in the blood making early detection difficult. Delayed diagnosis and delayed optimal therapy of BSIs are associated with increased morbidity and mortality.
This study seeks to identify whether next generation sequencing (NGS) of pathogens can identify patients with impending bloodstream infection. This would enable preemptive targeted therapy to replace antibacterial prophylaxis which often leads ot high-density broad-spectrum antibiotic exposure and contributes to subsequent development of antibiotic resistance.
PRIMARY OBJECTIVE:
Plasma samples collected but not required for clinical care (discarded samples) will be collected and stored. Results of NGS will be compared between patients who develop BSI immediately (within 72 hours) after sample collection, those who develop other infectious syndromes, and those who remain well. Clinical data describing baseline information about the patient and malignancy, antibiotic and chemotherapy exposure, microbiology testing, hematology results, and infection-related events will be collected prospectively from the electronic medical record.
An initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. The study may then enroll up to 200 participants to collection additional data for analysis.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of NGS-positive results | To estimate the sensitivity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-positive results in all positive BSI cultures will be given. | Once (within 72 hours of enrollment) |
| Proportion of NGS-negative results | To estimate the specificity of next generation pathogen sequencing for prediction of BSI, the proportion of NGS-negative results in all negative BSI cultures will be given. | Once (within 72 hours of enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who are being treated at St. Jude Children's Research Hospital and who have a high risk of infection.
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Wolf, MBBS, BA | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41780551 | Derived | Wolf J, Goggin KP, Inaba Y, Allison KJ, Ahmed AA, Maron G, Ferrolino J, Lazure L, Kohler C, Brenner A, Sun Y, Tang L, Gonzalez-Pena V, Rubnitz JE, Gawad C, Margolis EB, Thomas P. Predicting bloodstream infection by plasma cell-free metagenomic sequencing: a prospective cohort study. Lancet Microbe. 2026 Apr;7(4):101312. doi: 10.1016/j.lanmic.2025.101312. Epub 2026 Mar 2. | |
| 31855231 |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Plasma samples collected but not required for clinical care will undergo next generation pathogen sequencing.
| Derived |
| Goggin KP, Gonzalez-Pena V, Inaba Y, Allison KJ, Hong DK, Ahmed AA, Hollemon D, Natarajan S, Mahmud O, Kuenzinger W, Youssef S, Brenner A, Maron G, Choi J, Rubnitz JE, Sun Y, Tang L, Wolf J, Gawad C. Evaluation of Plasma Microbial Cell-Free DNA Sequencing to Predict Bloodstream Infection in Pediatric Patients With Relapsed or Refractory Cancer. JAMA Oncol. 2020 Apr 1;6(4):552-556. doi: 10.1001/jamaoncol.2019.4120. |
| Clinical Trials Open at St. Jude | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |