Clinical trial NCT05355675: The Association of Microbiota Composition With cGVHD After Allo-HSCT
Official title: The Association of Microbiota Composition With Chronic Graft Versus Host Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematopoietic Stem Cell Transplantation
Hematologic Malignancy
Chronic Graft-versus-host-disease
Complication
Keywords: hematopoietic stem cell transplantation
microbiota
metabolomics
chronic graft versus host disease
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hematologic malignancies planned to be treated by allogeneic hematopoietic cell transplantation

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 criteria: 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

Primary outcomes:
measure: Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation
timeFrame: 100 days
Secondary outcomes:
measure: 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)
timeFrame: 100 days
measure: To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes
timeFrame: 100 days
measure: To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
timeFrame: 100 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medicine University
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Jinhua
country: China
facility: Jinhua Hospital of Zhejiang University
city: Ningbo
country: China
facility: Ningbo Hospital of Zhejiang University
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
Study officials:
affiliation: First Affilaated Hospital of Medical School of Zhejiang University
name: Yi Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: