Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT: Cohort Study

NCT ID: NCT06386445

Last Updated: 2024-04-26

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

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease,acute kidney injury, and major adverse cardiac events within 100 days after transplantation,the secondary objective is to observe the high-risk factors for early complications.

Detailed Description

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This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Baseline characterisitcs of patients, including gender, age, disease type, transplant type, donor gender and age, pre-transplant baseline electrocardiogram, myocardial enzymology, renal function, and other indicators were recorded. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease,acute kidney injury, and major adverse cardiac events within 100 days after transplantation,the secondary objective is to observe the high-risk factors for early complications.

Conditions

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Stem Cell Transplant Complications Acute Graft Versus Host Disease Acute Kidney Injury Major Adverse Cardiac Events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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XJTU Cohort of allo-HSCT

all the patients underwent allogeneic stem cell transplantation

Serum metabolomics sequencing

Intervention Type OTHER

Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.

Interventions

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Serum metabolomics sequencing

Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≤ 65 years old;

Gender unlimited;

Normal heart and kidney function before transplantation;

Patients with indications for allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria

* CREA or BUN higher than the normal upper limit value before transplantation;

Individuals with a history of arrhythmia, heart failure, or PCI stent implantation prior to transplantation;

Patients with mental illness;

Those who are unwilling to sign informed consent.
Minimum Eligible Age

0 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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pengcheng he, M.D.

Role: STUDY_DIRECTOR

First Affiliated Hospital Xi'an Jiaotong University

Central Contacts

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xiaonig wang, M.D.

Role: CONTACT

02985323473

Other Identifiers

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XJTU1AF-CRF-2023-XK013

Identifier Type: -

Identifier Source: org_study_id

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