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Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT02330692
Recruitment Status : Recruiting
First Posted : January 5, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
Developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of Myelodysplastic Syndrome (MDS) patients at diagnosis and relapse.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome Other: No intervention

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Study Start Date : September 2013
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2023

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. the number of patients with MDS to examine new prognostic factors [ Time Frame: 10 years ]

Biospecimen Retention:   Samples Without DNA
Acquisition and storage of blood and bone marrow samples at diagnosis, at response evaluation and at times of relapse or refractory period.

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are diagnosed with MDS in Severance Hospital. All patients are eligible for study occuring from the starting day of the study. Patients are enrolled if the written consent are acquired. Considering the annual incidence rate of the disease, target patient population is 1,000 people during the study period.
Criteria

Inclusion Criteria:

  • MDS diagnosed by bone marrow aspiration and biopsy at Severance Hospital.

    • Male and Female over 16 years of age. ③ Written consent of the patient to participate in the cohort ④ Deaths during the study period are waiver of consent

Exclusion Criteria:

① Refusal or trouble understanding the written consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330692


Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joon-Won Cheong, MD, Ph.D    82-2-2228-1970      
Sponsors and Collaborators
Yonsei University
More Information
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Additional Information:

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02330692    
Other Study ID Numbers: 4-2013-0479
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
 Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms