The Association of Microbiota Composition With cGVHD After Allo-HSCT

NCT ID: NCT05355675

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Hematopoietic Stem Cell Transplantation Hematologic Malignancy Chronic Graft-versus-host-disease Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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observational group

Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment

blood sample

Intervention Type OTHER

collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

stool sample

Intervention Type OTHER

collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

control group

health control group: healthy volunteers

blood sample

Intervention Type OTHER

collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

stool sample

Intervention Type OTHER

collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

Interventions

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blood sample

collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

Intervention Type OTHER

stool sample

collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Yi Luo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Luo, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affilaated Hospital of Medical School of Zhejiang University

Locations

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The first Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

First Affiliated Hospital of Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

Hangzhou, , China

Site Status RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, , China

Site Status RECRUITING

Jinhua Hospital of Zhejiang University

Jinhua, , China

Site Status RECRUITING

Ningbo Hospital of Zhejiang University

Ningbo, , China

Site Status RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, , China

Site Status RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, , China

Site Status RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Luo, M.D.

Role: CONTACT

+86057187233801

Yibo Wu, M.D.

Role: CONTACT

+8619858876273

Facility Contacts

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Yi Luo, M.D.

Role: primary

+86057187233801

Baodong Ye, MD

Role: primary

+8657187236706

Yang Xu, MD

Role: primary

+8657187236706

Haowen Xiao, MD

Role: primary

+86057187236706

Jianping Lan, MD

Role: primary

+8657187236706

Huixian Hu, MD

Role: primary

Guifang Ouyang, MD

Role: primary

+86057187233801

Ying Chen, MD

Role: primary

Ying Lu, MD

Role: primary

+86057187236706

Yi Chen, MD

Role: primary

+8657187236706

Other Identifiers

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ZJU-HSCT-microbe

Identifier Type: -

Identifier Source: org_study_id

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