The Oronasal Microbiota in Pediatric Oncology Patients
Condition: Acute Myeloid Leukemia; Hematologic Malignancy; Bone Marrow Transplantation
MeSH terms: Hematologic Neoplasms
Study type: Observational

Summary: 
      The human microbiome is composed of unique groups of microorganisms occupying distinct
      habitats distributed throughout the human body. The Human Microbiome Project recently
      evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men) body
      sites. Much initial attention in the field of microbiome research has focused on the
      bacterial contribution to a "healthy" microbiome. However, it is clear that other
      microorganisms, including fungi and viruses, are also distributed throughout the human body
      and serve as functional components of the microbiome.

      The populations of microorganisms residing within the oral and nasal cavities make important
      contributions to human health and disease. These contributions may be especially important in
      immunosuppressed patients, including those patients receiving myelosuppressive chemotherapy
      or undergoing hematopoietic stem cell transplantation. In these patients, organisms typically
      considered as commensals can become pathogenic, either locally or systemically.

      This observational study is primarily undertaken to evaluate the oral and nasal microbiota
      and to define the population of fungal organisms residing within the oral and nasal cavities
      in pediatric oncology patients before and after receiving protocol-directed chemotherapy and
      associated supportive care.
    

Detailed description: 
      Participants will be recruited from the patient population at the St. Jude Children's
      Research Hospital (SJCRH). Participants will be enrolled in the study according to their
      underlying primary diagnosis: acute myeloid leukemia (AML) and in patients undergoing
      hematopoietic stem cell transplantation (HSCT).

      Patients will be asked to provide an oral wash and nasal swab sample at three time points
      during the course of their treatment at SJCRH. These samples will be used to characterize
      comprehensively the oronasal microbiota.

        -  Group 1 will include 30 patients with newly diagnosed AML. Within 72 hours of the start
           of chemotherapy, patients will provide an oral rinse and nasal swab sample. Participants
           will provide two subsequent oral rinse and nasal swab samples. The first (second total
           oral rinse and nasal swab sample) will be provided within 7 days of completion of
           "induction II" of therapy. The second (third total oral rinse and nasal swab sample)
           will be collected within 7 days of completion of therapy.

        -  Group 2 will include 30 allogeneic HSCT recipients. Prior to beginning their
           conditioning regimen, patients will provide an oral rinse and nasal swab sample.
           Participants will provide two subsequent oral rinse and nasal swab samples. The first
           (second total oral rinse and nasal swab sample) will be collected after completing their
           conditioning regimen on day +10 (plus or minus 7 days). The second (third total oral
           rinse and nasal swab sample) will be collected on day +30 (plus or minus 7 days).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children receiving care at SJCRH with new hematologic malignancies, as well as patients
        scheduled for HSCT, will be approached to participate in the study.
      
Keywords: Microbiome; Mycobiome; Virome; Pediatric leukemia; Pediatric bone marrow transplantation