Previous studies had found that the microbe in intestinal after allogeneic hematopoietic cell transplantation(allo-HSCT) were closely associated with overall survival and post-transplantation complications, especially graft versus host disease (GVHD).Due to the limited data on the association of microbiota composition with chronic GVHD(cGVHD) after allogeneic hematopoietic stem cell transplantation, the relationship between microbiota composition and post-transplantation complications, especially cGVHD, needs to be further evaluated.Detailed studies of the microbiome and host immune system will lead to the discovery of microbiome markers for early identification of patients at high risk for cGVHD. This may regulate patients' gut microbiota in an individualized manner to achieve optimal treatment outcomes while avoiding severe post-transplant cGVHD. We will operate a prospective, multicenter, nonrandomized, observational study. Patients will be asked to provide blood and stool samples during allo-HSCT.
Previous studies had found that the microbe in intestinal after allogeneic hematopoietic cell transplantation(allo-HSCT) were closely associated with overall survival and post-transplantation complications, especially graft versus host disease (GVHD).Due to the limited data on the association of microbiota composition with chronic GVHD(cGVHD) after allogeneic hematopoietic stem cell transplantation, the relationship between microbiota composition and post-transplantation complications, especially cGVHD, needs to be further evaluated.Detailed studies of the microbiome and host immune system will lead to the discovery of microbiome markers for early identification of patients at high risk for cGVHD. This may regulate patients' gut microbiota in an individualized manner to achieve optimal treatment outcomes while avoiding severe post-transplant cGVHD. We will operate a prospective, multicenter, nonrandomized, observational study. Patients will be asked to provide blood and stool samples during allo-HSCT. This blood will be used for plasma banking for further analysis, including miR, chemokine and metabonomics detection. Stool will be used for microbiome studies - isolation of total DNA/RNA and 16S rRNA gene sequencing for bacterial taxonomic classification. Furthermore, metagenomic sequencing and subsequent taxonomic and functional classification of microbial genes will be used.
Study Type
OBSERVATIONAL
Enrollment
300
collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGFirst Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, China
RECRUITINGSecond Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGSir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Hangzhou, China
RECRUITINGZhejiang Provincial People's Hospital
Hangzhou, China
RECRUITINGJinhua Hospital of Zhejiang University
Jinhua, China
RECRUITINGNingbo Hospital of Zhejiang University
Ningbo, China
RECRUITINGThe Affiliated People's Hospital of Ningbo University
Ningbo, China
RECRUITINGThe Affiliated People's Hospital of Ningbo University
Ningbo, China
RECRUITINGThe First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
RECRUITINGMicrobial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation
Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation
Time frame: 100 days
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the post-transplant complications in allogeneic transplant settings (cGVHD, overall survival, non-relapse mortality, replase, infectious complications)
To assess microbial changes with toxicity of therapy
Time frame: 100 days
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes
To correlate microbial changes with the quality of life which measured by Short Form 36 (SF-36) and and Functional Assessment of Chronic Illness Therapy with BMT subscale (FACT-BMT)
Time frame: 100 days
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
To correlate microbial changes with the patients nutrition. Clinical and biological nutritional assessments included anthropometric measurements, serum nutritional proteins, body composition assessed by bioelectrical impedance, and upper-limb muscle strength (MS) measured by dynamometry.
Time frame: 100 days
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