Follow-up Study of ICUS and CCUS Patients

NCT04428489 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Observational

Started

2011-01-01

Last updated

2025-12-29

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Observation and necessary supportive care

Observation and necessary supportive care: For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Culumative transformation rate — 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.

Trial sites (1)

Facility	City	Region	Status
The First Affliated Hospital of Soochow University	Suzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04428489 on ClinicalTrials.gov ↗ ← All trials in China