PREDSEQ: Identifying Infections Early in Children and Adolescents with Cancer

Prediction of Adverse Events in Children and Adolescents with Cancer at High Risk of Infection

Categories:

Supportive Infectious Diseases Studies

Genetics & Genomics

Diseases Treated:

None

Eligibility Overview:

This is a non-therapeutic clinical trial that is open only to St. Jude patients.

  • Younger than 25 years
  • Undergoing cancer therapy at St. Jude Children’s Research Hospital
  • Considered to be at high risk of infection
  1. Brief Summary

    Most 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.

    Traditionally, a blood culture is used to determine if pathogens are present. Although culture-based diagnostic techniques are important, they require a significant load of live bacteria in the blood. In early bacteremia or focal infection preceding bacteremia, blood cultures are typically negative.

    Delayed diagnosis and delayed optimal therapy of bloodstream infection is associated with increased morbidity and mortality. Novel diagnostic tools are needed to speed up the identification and characterization of these infections. Ideally, a predictive test would identify patients with impending bloodstream infection to enable pre-emptive targeted therapy.

    Next generation sequencing (NGS) of pathogens may be a tool to identify the presence of pathogen nucleic acids in sterile sites. In preliminary studies, next generation sequencing performed with blood culture appears to be sensitive and specific for diagnosis of BSI. However, testing prior to onset of bacteremia has not been assessed.

    In this clinical trial, we will conduct next generation sequencing on leftover blood samples taken from patients undergoing cancer treatment at St. Jude.

    Primary Objective

    • To determine if next generation sequencing can identify the presence of pathogens in blood prior to the onset of clinical bloodstream infection

    Eligibility Criteria

    Inclusion criteria include:

    • Younger than 25 years
    • Undergoing cancer therapy at St. Jude Children’s Research Hospital
    • Expected to receive care at St. Jude for at least 7 days
    • In a category of patients who are considered to be at high risk of infection

    Exclusion Criteria include:

    • Any condition that would place the patient at an unacceptable risk of injury or unable to meet the study requirements

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee

  2. About this study

    Your blood and tissues contain DNA, which serves as the “instruction book” for the cells that make up our bodies. Each person’s DNA is unique. Bacteria, viruses and other infectious organisms also contain DNA and can be identified by finding the unique code for each type.

    Researchers in this study want to see if they can detect potential infections by looking at DNA in your blood. Researchers hope the process may reveal new information about how genes interact with other factors to cause disease, affect treatments or the outcome of a disease.

    During your cancer treatment, standard blood testing will be done. Researchers will use any leftover blood from these standard tests to run the new, DNA blood test. They will also review your medical history, collect information about the drugs you take and learn about any infections you may develop.

    The DNA test is not approved by the U.S. Food and Drug Administration (FDA).

    Purpose of this clinical trial

    The main goal of this study is to learn whether new tests to identify DNA in the blood can detect an infection, or risk of relapse, earlier than standard tests.

    Eligibility overview

    • Younger than 25 years
    • Undergoing cancer therapy at St. Jude Children’s Research Hospital
    • Considered to be at high risk of infection
  3. PREDSEQ Quick View
    Sponsor St. Jude Children’s Research Hospital
    ClinicalTrials.gov Identifier NCT03226158
    Trial Start Date August 2017
    Estimated Enrollment 200
    Study Type Observational
    Conditions Cancer
    Ages Younger than 25 years old
    Principal Investigator Josh Wolf, MBBS
    Study Sites St. Jude Children’s Research Hospital
    For a consultation or to discuss PREDSEQ St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Josh Wolf, MBBS

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.