Follow-up Study of ICUS and CCUS Patients

Soochow University

Status: Invitation-only

Conditions: Myelodysplastic Syndromes

Treatments: Other: Observation and necessary supportive care

Study type: Observational

Funder types: Other

Identifiers

NCT04428489

SZcytopenia01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

300 participants in 2 patient groups

Idiopathic cytopenia of undetermined significance (ICUS)

Treatment:

Other: Observation and necessary supportive care

Clonal cytopenia of unknown significance (CCUS)

Treatment:

Other: Observation and necessary supportive care