A Follow-up Observational Study of ICUS and CCUS Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- The First Affiliated Hospital of Soochow University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Culumative transformation rate
- Status
- Enrolling By Invitation
- Last Updated
- 4 months ago
Overview
Brief Summary
The proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions has been released by an international consensus group. Based on the criteria, patients with persistent cytopenia could be diagnosed with MDS, CCUS and ICUS. However, the process and outcome of pre-MDS conditions (CCUS, ICUS) is still to be characterized in Chinese population. We design this prospective observational study to explore the disease process and outcome in ICUS and CCUS patients.
Investigators
Sheng-Li Xue, MD
Associate Professor
The First Affiliated Hospital of Soochow University
Eligibility Criteria
Inclusion Criteria
- •Patients with cytopenia of any degree in one or more lineages: erythrocytes, neutrophils, or platelets. And the cytopenia has to be persistent (≥ 4 months) and lacking minimal diagnostic criteria of MDS.
Exclusion Criteria
- •Patients with cytopenia which could be explained by any other hematologic or non-hematologic disease.
Outcomes
Primary Outcomes
Culumative transformation rate
Time Frame: 5 years
Transformation is defined as progression from ICUS to CCUS, ICUS to MDS or CCUS to MDS. All patients are followed-up since entry into this trial and transformation events are recorded. Cumulative transformation rate is defined for all patients and estimated by competing risk methods.
Secondary Outcomes
- Event-free survival(5 years)