The Oronasal Microbiota in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Diversity index of oronasal fungal microbiome (mycobiome)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diversity index of oronasal fungal microbiome (mycobiome)
时间窗: 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
时间窗: 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.
次要结局
- Diversity index of 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 bacterial 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))