The Oronasal Microbiota in Pediatric Oncology Patients

NCT02949427 | Completed

• 1 other identifier: ORIOME
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia; Hematologic Malignancy; Bone Marrow Transplantation

Keywords

Microbiome; Mycobiome; Virome; Pediatric leukemia; Pediatric bone marrow transplantation

Outcome Measures

Primary Outcomes (2)

• Diversity index of oronasal fungal microbiome (mycobiome)

  Diversity index is a measure of the richness of microbial species present in the sample. It is a single summary continuous numerical quantity for each sample.

  Start of therapy through completion of therapy (up to 2 years)

• Relative abundance of the oronasal fungal microbiome

  Relative abundance is percentage of each taxa of fungal, describing which fungal species are detected in a sample.

  Start of therapy through completion of therapy (up to 2 years)

Secondary Outcomes (4)

• Diversity index of oronasal bacterial microbiome

  Start of therapy through completion of therapy (up to 2 years)

• Relative abundance of the oronasal bacterial microbiome

  Start of therapy through completion of therapy (up to 2 years)

• Diversity index of the oronasal viral microbiome

  Start of therapy through completion of therapy (up to 2 years)

• Relative abundance of the oronasal viral microbiome

  Start of therapy through completion of therapy (up to 2 years)

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients aged 4 to 21 years.
• Group 1: Patients with newly confirmed diagnosis of acute myeloid leukemia (AML).
• Group 2: Patients scheduled to receive conditioning for allogeneic HSCT within 7 days.

You may not qualify if:

• Patients in group 1 who have received chemotherapy for more than 72 hours prior to enrollment (group 1) or started preparative regimen for allogenic stem cell transplant (group 2).
• Patients who are unable to perform the oral rinse or nasal swab collection procedure.
• Patients who have any condition that would place them at unnecessary risk secondary to providing oral and nasal samples.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent for study participation.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site

Study Officials

• Gabriela Maron Alfaro, MD

  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: October 20, 2016
• First Posted: October 31, 2016
• Study Start: March 6, 2017
• Primary Completion: July 25, 2022
• Study Completion: March 29, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)