The Association of Microbiota Composition With cGVHD After Allo-HSCT

Zhejiang University

Status: Enrolling

Conditions: Hematologic Malignancy; Complication; Chronic Graft-versus-host-disease; Hematopoietic Stem Cell Transplantation

Treatments: Other: stool sample; Other: blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT05355675

ZJU-HSCT-microbe

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

observational group

Description:

Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment

Treatment:

Other: stool sample

Other: blood sample

control group

Description:

health control group: healthy volunteers

Treatment:

Other: stool sample

Other: blood sample