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NCT04428489 Clinical Trial

Follow-up Study of ICUS and CCUS Patients

Myelodysplastic Syndromes Clinical Trial

Official title:
A Follow-up Observational Study of ICUS and CCUS Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04428489
Other study ID # SZcytopenia01
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China The First Affliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Culumative transformation rate 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. 5 years
Secondary Event-free survival 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. 5 years
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