Follow-up Study of ICUS and CCUS Patients
A Follow-up Observational Study of ICUS and CCUS Patients
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 29, 2025
December 1, 2025
16 years
June 9, 2020
December 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Event-free survival
5 years
Study Arms (2)
Idiopathic cytopenia of undetermined significance (ICUS)
Clonal cytopenia of unknown significance (CCUS)
Interventions
For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.
Eligibility Criteria
Patients diagnosed with ICUS and CCUS based on the proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions
You may qualify if:
- 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.
You may not qualify if:
- Patients with cytopenia which could be explained by any other hematologic or non-hematologic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 11, 2020
Study Start
January 1, 2011
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12