The Association of Microbiota Composition With cGVHD After Allo-HSCT

Hematologic Malignancy Clinical Trial

Official title:

The Association of Microbiota Composition With Chronic Graft Versus Host Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355675
• Other study ID #: ZJU-HSCT-microbe
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Graft-versus-host-disease
• Complication
• Graft vs Host Disease
• Hematologic Malignancy
• Hematologic Neoplasms
• Hematopoietic Stem Cell Transplantation

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