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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diversity index of oronasal bacterial microbiome | 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 bacterial microbiome |
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Inclusion Criteria:
Exclusion Criteria:
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Children receiving care at SJCRH with new hematologic malignancies, as well as patients scheduled for HSCT, will be approached to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Maron Alfaro, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Relative abundance is percentage of each taxa of bacteria, describing which bacterial species are detected in a sample. |
| Start of therapy through completion of therapy (up to 2 years) |
| Diversity index of the oronasal viral microbiome | 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 viral microbiome | Relative abundance is percentage of each taxa of viruses, describing which viral species are detected in a sample. | Start of therapy through completion of therapy (up to 2 years) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |