Next Generation Pathogen Sequencing for Prediction of Adverse Events

NCT03226158 | Active Not Recruiting

• 1 other identifier: PREDSEQ
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bloodstream Infection

Keywords

Next generation pathogen sequencing (NGPS); Pediatric; Cancer; Bloodstream infection (BSI)

Outcome Measures

Primary Outcomes (2)

• 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)

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are being treated at St. Jude Children's Research Hospital and who have a high risk of infection.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karius, Inc.: collaborator
• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (2)

• 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. 2027 Feb 2:101312. doi: 10.1016/j.lanmic.2025.101312. Online ahead of print.

  PMID: 41780551 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.

  PMID: 31855231 DERIVED

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples collected but not required for clinical care will undergo next generation pathogen sequencing.

MeSH Terms

Conditions

Sepsis; Neoplasms

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Wolf, MBBS, BA

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: August 9, 2017
• Primary Completion: March 1, 2022
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)