Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myeloid Leukemia
  • Bone Marrow Transplantation
  • Hematologic Malignancy
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 4 years and 21 years
Gender
Both males and females

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...

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).

Tracking Information

NCT #
NCT02949427
Collaborators
Not Provided
Investigators
Principal Investigator: Gabriela Maron Alfaro, MD St. Jude Children's Research Hospital