Follow-up Study of ICUS and CCUS Patients

• Conditions: Myelodysplastic Syndromes
• Interventions: Other: Observation and necessary supportive care

• Registration Number: NCT04428489
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic cytopenia of undetermined significance (ICUS)	Observation and necessary supportive care	-
Clonal cytopenia of unknown significance (CCUS)	Observation and necessary supportive care	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Event-free survival	5 years	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.

Trial Locations

Locations (1)

The First Affliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China