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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observational group | Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment |
| |
| control group | health control group: healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Other | collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial 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 | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 100 days |
| To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes |
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Inclusion Criteria:
Exclusion Criteria:
patients not-matching inclusion criteria
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patients with hematologic malignancies planned to be treated by allogeneic hematopoietic cell transplantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Luo, M.D. | Contact | +86057187233801 | luoyijr@163.com | |
| Yibo Wu, M.D. | Contact | +8619858876273 | wuyibo7@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Luo, M.D. | First Affilaated Hospital of Medical School of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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This blood will be used for plasma banking for further analysis, including miR and chemokine 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.
| stool sample | Other | collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation |
|
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) |
| 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. | 100 days |
| First Affiliated Hospital of Zhejiang Chinese Medicine University | Recruiting | Hangzhou | Zhejiang | China |
|
| Second Affiliated Hospital of Zhejiang University, School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | China |
|
| Jinhua Hospital of Zhejiang University | Recruiting | Jinhua | China |
|
| Ningbo Hospital of Zhejiang University | Recruiting | Ningbo | China |
|
| The Affiliated People's Hospital of Ningbo University | Recruiting | Ningbo | China |
|
| The Affiliated People's Hospital of Ningbo University | Recruiting | Ningbo | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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