The Oronasal Microbiota in Pediatric Oncology Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 4 - 21 |
| Updated: | 7/14/2018 |
| Start Date: | March 6, 2017 |
| End Date: | November 30, 2021 |
| Contact: | Gabriela Maron Alfaro, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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.
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.
- 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).
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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Gabriela Maron Alfaro, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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