Clinical trial · Observational
Next Generation Pathogen Sequencing for Prediction of Adverse Events
Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection (PREDSEQ)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: * To estimate the sensitivity and specificity of next generation pathogen sequencing for prediction of bloodstream infection in children with cancer at high risk of infection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bloodstream Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Proportion of NGS-positive results
- timeFrame
- Once (within 72 hours of enrollment)
- description
- 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.
- measure
- Proportion of NGS-negative results
- timeFrame
- Once (within 72 hours of enrollment)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: * Under 25 years of age at time of study enrollment * Undergoing care for cancer at St. Jude * In a category of patients who are considered by the investigator to be at high risk of infection * Expected to receive care at St. Jude for at least 7 days Exclusion Criteria: * Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
References
Publications (2)
- DERIVEDWolf 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. PMID 41780551
- DERIVEDGoggin 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. PMID 31855231