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Follow-up Study of ICUS and CCUS Patients

NCT ID: NCT04428489

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Myelodysplastic Syndromes

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic cytopenia of undetermined significance (ICUS)

Observation and necessary supportive care

Intervention Type OTHER

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

Clonal cytopenia of unknown significance (CCUS)

Observation and necessary supportive care

Intervention Type OTHER

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

Interventions

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Observation and necessary supportive care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Li Xue, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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SZcytopenia01

Identifier Type: -

Identifier Source: org_study_id