- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04428489
Follow-up Study of ICUS and CCUS Patients
April 16, 2024 updated by: Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
A Follow-up Observational Study of ICUS and CCUS Patients
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- The First Affliated Hospital of Soochow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with ICUS and CCUS based on the proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Idiopathic cytopenia of undetermined significance (ICUS)
|
For patients with ICUS and CCUS, necessary supportive care could be given.
No addtitional treatment is administrated.
|
Clonal cytopenia of unknown significance (CCUS)
|
For patients with ICUS and CCUS, necessary supportive care could be given.
No addtitional treatment is administrated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Culumative transformation rate
Time Frame: 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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival
Time Frame: 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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 9, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SZcytopenia01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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