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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic cytopenia of undetermined significance (ICUS) |
| ||
| Clonal cytopenia of unknown significance (CCUS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation and necessary supportive care | Other | For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Culumative transformation rate | 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Defined for all patients entry into this trial; measured from the date of entry into this trial to the date of progression or death from any cause; patients not known to have any of these events are censored on the date they were last examined. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with ICUS and CCUS based on the proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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