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Enrolling by invitation NCT04428489

Follow-up Study of ICUS and CCUS Patients

— Observational Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation and necessary supportive care.
Who it may be relevant to
Registry conditions: Myelodysplastic Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Follow-up Observational Study of ICUS and CCUS Patients

Overview

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

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

Primary outcome measures

  • Culumative transformation rate [Time frame: 5 years]
Secondary outcome measures (1)
  • Event-free survival [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Affliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT04428489 · SZcytopenia01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗