The Association of Microbiota Composition With cGVHD After Allo-HSCT

Recruiting

• Conditions: Complication; Chronic Graft-versus-host-disease; Hematopoietic Stem Cell Transplantation; Hematologic Malignancy
• Interventions: Other: blood sample; Other: stool sample

• Registration Number: NCT05355675
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-27
• Study Start: 2022-05-01
• Study First Posted: 2022-05-02
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-31
• Last Update Posted: 2022-08-02
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	stool sample	health control group: healthy volunteers
observational group	stool sample	Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment
observational group	blood sample	Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment
control group	blood sample	health control group: healthy volunteers

Primary Outcome Measures

Name	Time	Method
Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation	100 days	Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation

Secondary Outcome Measures

Name	Time	Method
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 assess microbial changes with toxicity of therapy
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes	100 days	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)
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status	100 days	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.

Trial Locations

Locations (9)

The first Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, 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 Wenzhou Medical University; 🇨🇳 Wenzhou, 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