Follow-up Study of ICUS and CCUS Patients

A Follow-up Observational Study of ICUS and CCUS Patients

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04428489

Enrollment

300

Registered

2020-06-11

Start date

2011-01-01

Completion date

2026-12-31

Last updated

2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

Idiopathic cytopenia of undetermined significance (ICUS), Clonal cytopenia of unknown significance (CCUS)

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.

Interventions

OTHERObservation and necessary supportive care

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026