Evaluating stem cells in myelodysplastic syndromes using advanced flow cytometry
Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
Peking University People's Hospital · NCT06569095
This study is trying to see if certain stem cells can help predict how well patients with myelodysplastic syndromes will do after they receive a stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 163 (estimated) |
| Ages | 15 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital (other) |
| Locations | 4 sites (Beijing and 3 other locations) |
| Trial ID | NCT06569095 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the predictive value of myelodysplastic syndrome stem cells (MDS-SC) in patients with myelodysplastic syndromes (MDS) undergoing allogeneic stem cell transplantation. Utilizing multiparameter flow cytometry (MFC), the study will investigate how effectively MDS-SC can predict patient outcomes post-transplantation. The research will be conducted across multiple centers, enhancing the reliability of the findings. The goal is to improve disease monitoring and treatment strategies for MDS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 15 to 70 diagnosed with myelodysplastic syndromes who can provide informed consent.
Not a fit: Patients with severe cardiac, hepatic, or renal diseases, uncontrolled serious infections, or other conditions that prevent them from tolerating transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of treatment outcomes for patients with myelodysplastic syndromes.
How similar studies have performed: Previous studies have shown that similar approaches using multiparameter flow cytometry for monitoring disease load in hematological conditions have been effective, suggesting potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing and 3 other locations
- Chinese PLA General Hospital — Beijing, China (RECRUITING)
- Peking University People's Hospital — Beijing, China (RECRUITING)
- Wuhan TongJi Hospital — Wuhan, China (RECRUITING)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (RECRUITING)
Study contacts
- Study coordinator: chief physician
- Email: rmcyj@bjmu.edu.cn
- Phone: 13520536738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myelodysplastic Syndromes