Hematologic Malignancy Clinical Trial
Official title:
The Association of Microbiota Composition With Chronic Graft Versus Host Disease
NCT number | NCT05355675 |
Other study ID # | ZJU-HSCT-microbe |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | May 31, 2025 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. aged between 18 years and 65 years 2. patients planned to be treated by allogeneic hematopoietic cell transplantation 3. signed written informed consent Exclusion Criteria: patients not-matching inclusion criteria |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Zhejiang Chinese Medicine University | Hangzhou | Zhejiang |
China | Second Affiliated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
China | Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University | Hangzhou | |
China | The first Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | Zhejiang Provincial People's Hospital | Hangzhou | |
China | Jinhua Hospital of Zhejiang University | Jinhua | |
China | Ningbo Hospital of Zhejiang University | Ningbo | |
China | The Affiliated People's Hospital of Ningbo University | Ningbo | |
China | The Affiliated People's Hospital of Ningbo University | Ningbo | |
China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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) | 100 days | |
Secondary | 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 |
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