Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry

NCT ID: NCT06569095

Last Updated: 2024-12-20

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

RECRUITING

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-09

Study Completion Date

2027-12-18

Brief Summary

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Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. In patients with acute myeloid leukemia, leukemia stem cells (LSCs) determined using MFC for leukemia load and MRD detection is superior to traditional MFC method. In the investigators previous single center study, the investigators demonstrated that detection of disease load, including MRD, by MFC in patients with MDS-EB is superior to predict outcomes after allogeneic stem cell transplantation. Here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of MDS-SC in patients with MDS-EB who received allografting.

Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MDS-EB

Detection of MDS-SC using MFC

Intervention Type OTHER

The aim of this study is to investigate the predictive values of MDS-SC determined by MFC for patients with MDS-EB who underwent allotransplantation.

Interventions

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Detection of MDS-SC using MFC

The aim of this study is to investigate the predictive values of MDS-SC determined by MFC for patients with MDS-EB who underwent allotransplantation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with Myelodysplastic syndromes;
* Between 15 and 70 years old;
* Subjects are able to provide written informed consent.

Exclusion Criteria

* Subjects who cannot comply with the study;
* Patient has severe cardiac (ejection fraction \<50%), hepatic (total bilirubin \>34μmol/L, ALT, AST \>2x upper limit of normal) or renal (blood creatinine \>130μmol/L) disease;
* Uncontrolled serious infection;
* Other conditions that do not tolerate transplantation or other therapies.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Wuhan TongJi Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Yingjun

Professor and Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Wuhan TongJi Hospital

Wuhan, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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chief physician

Role: CONTACT

Phone: 13520536738

Email: [email protected]

Facility Contacts

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Hai-Yan Zhu

Role: primary

Ying-Jun Chang, PhD

Role: primary

Yi-Cheng Zhang

Role: primary

Zhi-Lei Bian, PhD

Role: primary

Other Identifiers

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PekingUPH Chang YJ

Identifier Type: -

Identifier Source: org_study_id