The Association of Microbiota Composition With cGVHD After Allo-HSCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| observational group Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment |
Other: blood sample
collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
Other: stool sample
collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
|
| control group health control group: healthy volunteers |
Other: blood sample
collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
Other: stool sample
collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
|
Outcome Measures
Primary Outcome Measures
- Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation [100 days]
Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation
Secondary Outcome Measures
- 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) [100 days]
To assess microbial changes with toxicity of therapy
- To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes [100 days]
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)
- To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status [100 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
aged between 18 years and 65 years
-
patients planned to be treated by allogeneic hematopoietic cell transplantation
-
signed written informed consent
Exclusion Criteria:
patients not-matching inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The first Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
| 2 | First Affiliated Hospital of Zhejiang Chinese Medicine University | Hangzhou | Zhejiang | China | |
| 3 | Second Affiliated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang | China | |
| 4 | Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University | Hangzhou | China | ||
| 5 | Zhejiang Provincial People's Hospital | Hangzhou | China | ||
| 6 | Jinhua Hospital of Zhejiang University | Jinhua | China | ||
| 7 | Ningbo Hospital of Zhejiang University | Ningbo | China | ||
| 8 | The Affiliated People's Hospital of Ningbo University | Ningbo | China | ||
| 9 | The Affiliated People's Hospital of Ningbo University | Ningbo | China | ||
| 10 | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | China |
Sponsors and Collaborators
- First Affiliated Hospital of Zhejiang University
Investigators
- Principal Investigator: Yi Luo, M.D., First Affilaated Hospital of Medical School of Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZJU-HSCT-microbe