Acute Myeloid LeukemiaNCT02949427
The Oronasal Microbiota in Pediatric Oncology Patients
An observational study of Acute Myeloid Leukemia and Hematologic Malignancy, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Acute Myeloid Leukemia, Hematologic Malignancy, Bone Marrow Transplantation
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 29 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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).
- Keywords
- Microbiome, Mycobiome, Virome, Pediatric leukemia, Pediatric bone marrow transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute, Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Start of therapy through completion of therapy (up to 2 years)
Secondary outcomes (4)
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.
Measured: Start of therapy through completion of therapy (up to 2 years)
Relative abundance of the oronasal bacterial microbiome
Relative abundance is percentage of each taxa of bacteria, describing which bacterial species are detected in a sample.
Measured: 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.
Measured: 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.
Measured: Start of therapy through completion of therapy (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start6 Mar 2017
- Primary completion25 Jul 2022
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriela Maron Alfaro, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949427
- Sponsor's protocol ID
- ORIOME
- Status last verified
- May 2026
- First submitted
- 20 Oct 2016
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oronasal Microbiota in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT02949427
- Acronym / sponsor ID
- ORIOME
- Keywords
- Microbiome, Mycobiome, Virome, Pediatric leukemia, Pediatric bone marrow transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diversity index of oronasal fungal microbiome (mycobiome)
Time frame: Start of therapy through completion of therapy (up to 2 years)
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.
Relative abundance of the oronasal fungal microbiome
Time frame: Start of therapy through completion of therapy (up to 2 years)
Relative abundance is percentage of each taxa of fungal, describing which fungal species are detected in a sample.
4 secondary outcomes
Diversity index of oronasal bacterial microbiome
Time frame: Start of therapy through completion of therapy (up to 2 years)
Relative abundance of the oronasal bacterial microbiome
Time frame: Start of therapy through completion of therapy (up to 2 years)
Diversity index of the oronasal viral microbiome
Time frame: Start of therapy through completion of therapy (up to 2 years)
Relative abundance of the oronasal viral microbiome
Time frame: Start of therapy through completion of therapy (up to 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Maron Alfaro, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Hematologic Malignancy, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diversity index of oronasal fungal microbiome (mycobiome) (time frame: Start of therapy through completion of therapy (up to 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.