Spots Global Cancer Trial Database for The Association of Microbiota Composition With cGVHD After Allo-HSCT
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Trial Identification
Brief Title: The Association of Microbiota Composition With cGVHD After Allo-HSCT
Official Title: The Association of Microbiota Composition With Chronic Graft Versus Host Disease
Study ID: NCT05355675
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
The first Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 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
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, , China
Contact Details
Name: Yi Luo, M.D.
Affiliation: First Affilaated Hospital of Medical School of Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
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