Hematopoietic Stem Cell TransplantationNCT05355675
The Association of Microbiota Composition With cGVHD After Allo-HSCT
An observational study of Hematopoietic Stem Cell Transplantation and Hematologic Malignancy, run by First Affiliated Hospital of Zhejiang University at 10 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Hematologic Malignancy, Chronic Graft-versus-host-disease
- What is being tested?
- blood sample and stool sample
- How many people
- 300 participants
- Where
- 10 sitesChina
- Study dates
- 1 May 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with hematologic malignancies planned to be treated by allogeneic hematopoietic cell transplantation
Who may be able to join
- aged between 18 years and 65 years
- patients planned to be treated by allogeneic hematopoietic cell transplantation
- signed written informed consent
Who cannot join
- patients not-matching inclusion criteria
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Yi Luo, M.D., +86057187233801, luoyijr@163.com
- Recruiting
First Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang
Baodong Ye, MD, +8657187236706, 13588453501@qq.com
- Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang
Yang Xu, MD, +8657187236706, zjuyujian@126.com
- Recruiting
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Hangzhou
Haowen Xiao, MD, +86057187236706, xiaohaowen@zju.edu.cn
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Jianping Lan, MD, +8657187236706, lanjp@163.com
- Recruiting
Jinhua Hospital of Zhejiang University
Jinhua
Huixian Hu, MD
- Recruiting
Ningbo Hospital of Zhejiang University
Ningbo
Guifang Ouyang, MD, +86057187233801, luoyijr@163.com
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo
Ying Chen, MD
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo
Ying Lu, MD, +86057187236706, luying741107@qq.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Yi Chen, MD, +8657187236706, chenyi19527@163.com
About this study
Official title: The Association of Microbiota Composition With Chronic Graft Versus Host Disease
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.
Read the 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.
- Conditions
- Hematopoietic Stem Cell Transplantation, Hematologic Malignancy, Chronic Graft-versus-host-disease, Complication
- Being tested
- blood sample, stool sample
- Keywords
- hematopoietic stem cell transplantation, microbiota, metabolomics, chronic graft versus host disease
- Medical subject headings
- Hematologic Neoplasms, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
collecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
stool sampleOther
collecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation
| Study group | Role | What they receive |
|---|---|---|
| observational group | Patients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment Receives: Other: blood sample; Other: stool sample | |
| control group | health control group: healthy volunteers Receives: Other: blood sample; Other: stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
To assess microbial changes with toxicity of therapy
Measured: 100 days
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)
Measured: 100 days
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.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 May 2022
- Primary completion1 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Luo, First Affiliated Hospital of Zhejiang University
- Investigators
- Yi Luo, M.D., Principal investigator, First Affilaated Hospital of Medical School of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355675
- Sponsor's protocol ID
- ZJU-HSCT-microbe
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Microbiota Composition With Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT05355675
- Acronym / sponsor ID
- ZJU-HSCT-microbe
- Conditions
- Hematopoietic Stem Cell Transplantation, Hematologic Malignancy, Chronic Graft-versus-host-disease, Complication
- Keywords
- hematopoietic stem cell transplantation, microbiota, metabolomics, chronic graft versus host disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observational group | – | Other: blood sample, Other: stool samplePatients with hematologic malignancies following allogeneic hematopoietic stem cell transplantation treatment |
| control group | – | Other: blood sample, Other: stool samplehealth control group: healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hematologic malignancies planned to be treated by allogeneic hematopoietic cell transplantation
Key inclusion criteria (3 listed)
- aged between 18 years and 65 years
- patients planned to be treated by allogeneic hematopoietic cell transplantation
- signed written informed consent
Key exclusion criteria (1 listed)
- patients not-matching inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplecollecting 15ml peripheral blood samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation | Other | control group, observational group |
| stool samplecollecting 50mg fresh stool samples at -7 days before transplantation and+28 days, +100 days, +1 years, +2 years after transplantation | Other | control group, observational group |
Primary outcome
Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation
Time frame: 100 days
Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation
3 secondary outcomes
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)
Time frame: 100 days
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes
Time frame: 100 days
To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status
Time frame: 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Hematopoietic Stem Cell Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Luo, M.D. principal investigator
First Affilaated Hospital of Medical School of Zhejiang University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation and Hematologic Malignancy, run by First Affiliated Hospital of Zhejiang University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Luo, M.D. (+86057187233801, luoyijr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.