ORIOME: Mouth and Nose Microorganisms in Childhood Cancer Patients

The Oronasal Microbiota in Pediatric Oncology Patients

Category:

Infectious Diseases

Diseases Treated:

Non-Therapeutic

Eligibility Overview:

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

  • Between 4 and 21 years old
  • Newly confirmed diagnosis of acute myeloid leukemia (AML) or scheduled to receive conditioning for allogeneic hematopoietic stem cell transplantation within seven days
  • Receiving treatment at St. Jude Children’s Research Hospital
  1. Brief Summary

    Patients receiving chemotherapy or undergoing hematopoietic stem cell transplantation are potentially at increased risk of local and systemic infectious complications resulting from changes in the composition of typical flora over time. There are currently no published studies comprehensively evaluating the oronasal mycobiome in pediatric oncology patients. This study will characterize the changes in the oral mycobiome structure and diversity associated with oncologic therapy.

    Primary Objective

    • Describe the oronasal fungal microbiome (mycobiome) in patients newly diagnosed with acute myeloid leukemia (AML) and patients undergoing hematopoietic stem cell transplantation (HSCT) at the start of therapy and at two additional times during oncologic treatment.

    Eligibility Criteria

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

    Inclusion criteria include:

    • Between 4 and 21 years old
    • Newly confirmed diagnosis of acute myeloid leukemia or scheduled to receive conditioning for allogeneic hematopoietic stem cell transplantation within seven days
    • Receiving treatment at St. Jude Children’s Research Hospital

    Exclusion Criteria include:

    • Unable to perform oral rinse or nasal swab collection procedure
    • Received chemotherapy for AML more than 72 hours prior to obtaining first oral rinse and swab samples
    • Started a preparative regimen for allogeneic HSCT

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    The human body is home to many tiny organisms such as bacteria, fungi and viruses. These organisms live in all parts of the body, including the nose and mouth. Scientists call this collection of tiny organisms the human microbiome. 

    Antibiotics and strong anti-cancer medicines, known as chemotherapy, change the microbiomes of cancer patients. This study will examine mycobiome changes in the noses and mouths of young cancer patients receiving chemotherapy or stem cell transplant at St. Jude Children’s Research Hospital.

    Purpose of this clinical trial

    The main purpose of this study is to learn more about the changes that occur in the mycobiome of the mouth and nose as a result of receiving cancer therapy.

    Eligibility overview

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

    • Between 4 and 21 years old
    • Newly confirmed diagnosis of acute myeloid leukemia (AML) or scheduled to receive conditioning for allogeneic hematopoietic stem cell transplantation within seven days
    • Receiving treatment at St. Jude Children’s Research Hospital
  3. ORIOME Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT02949427
    Trial Start Date October 2016
    Estimated Enrollment 60
    Study Type Observational
    Conditions Acute Myeloid Leukemia or scheduled for HSCT
    Ages Between 4 and 21 years old
    Principal investigator Gabriela Maron, MD
    Study Sites St. Jude Children’s Research Hospital
    For a consultation or to discuss ORIOME St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Gabriela Maron, MD

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.