The Association of Microbiota Composition With cGVHD After Allo-HSCT
1 other identifier
observational
300
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedAugust 2, 2022
July 1, 2022
3 years
April 20, 2022
July 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes
100 days
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
100 days
Study Arms (2)
observational group
Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment
control group
health control group: healthy volunteers
Interventions
collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
Eligibility Criteria
patients with hematologic malignancies planned to be treated by allogeneic hematopoietic cell transplantation
You may qualify if:
- aged between 18 years and 65 years
- patients planned to be treated by allogeneic hematopoietic cell transplantation
- signed written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, 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
Biospecimen
This blood will be used for plasma banking for further analysis, including miR and chemokine 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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Luo, M.D.
First Affilaated Hospital of Medical School of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 20, 2022
First Posted
May 2, 2022
Study Start
May 1, 2022
Primary Completion
May 1, 2025
Study Completion
May 31, 2025
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share