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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date July 2022
Source First Affiliated Hospital of Zhejiang University
Contact Yi Luo, M.D.
Phone +86057187233801
Email luoyijr@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
blood sample
collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
stool sample
collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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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