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Chronic Myelod Leukemia Registry at Asan Medical Center

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ClinicalTrials.gov Identifier: NCT01761695
Recruitment Status : Terminated (The PI resigned the institute. The rest investigators at the institute decided to terminate the study.)
First Posted : January 7, 2013
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dae-Young Kim, Asan Medical Center

Tracking Information
First Submitted Date January 3, 2013
First Posted Date January 7, 2013
Last Update Posted Date July 20, 2018
Study Start Date January 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2013)
Overall survival [ Time Frame: 30 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2013)
  • Event-free survival [ Time Frame: 30 years ]
    Definition of events will be as 'failure', 'progress to AP/BC', 'intolerant and medication change', and 'death from any cause'.
  • Failure-free survival [ Time Frame: 30 years ]
    Failure will be defined as BCR-ABL elevation at 2 serial times, progression to AP/BC, loss of hematologic / cytogenetic response, any appearance of ABL kinase mutation, and clonal evolution.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Myelod Leukemia Registry at Asan Medical Center
Official Title Prospective Observational Cohort Registry for Patients With Chronic Myeloid Leukemia at Asan Medical Center
Brief Summary The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.
Detailed Description
  1. Acquisition of informed concent form
  2. Data acquisition from medical record including

    • demographic / disease-associated factors
    • details of treatment, and its results
    • complications during treatment
    • genetic data
    • survival outcome (upto 30 years)
  3. Accumulation of data for 30 years
  4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Years
Biospecimen Retention:   Samples With DNA
Description:
Bone marrow aspirate or peripheral blood (for its mononuclear cells) will be collected, processed, and cryopreserved for future analysis of DNA or cell culture. Acquisition of biospecimens will be proceeded if patient agree with the informed consent for donation of biospecimen to 'Asan Medical Center Biomaterial Resource Banking Center'. This registry data will be used as a basic demographic and clinical information for the biospecimens.
Sampling Method Non-Probability Sample
Study Population Patients who are diagnosed and/or treated with chronic myeloid leukemia at Asan Medical Center, Seoul, Korea
Condition
  • Leukemia, Chronic Myeloid
  • Myeloid Leukemia, Chronic, Accelerated Phase
  • Myeloid Leukemia, Chronic, Chronic Phase
Intervention Other: Diagnosed as CML
All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047
Other Name: Diagnosed as chronic myeloid leukemia
Study Groups/Cohorts
  • CML CP
    Diagnosed as CML with chronic phase
    Intervention: Other: Diagnosed as CML
  • CML AP
    Diagnosed as CML with accelerated phase
    Intervention: Other: Diagnosed as CML
  • CML BC
    Diagnosed as CML with blast crisis
    Intervention: Other: Diagnosed as CML
  • CML other
    Diagnosed as CML, which is not included in any of other category
    Intervention: Other: Diagnosed as CML
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 22, 2016)
100
Original Estimated Enrollment
 (submitted: January 3, 2013)
1050
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients who are diagnosed and/or treated as chronic myeloid leukemia at Asan Medical Center
  • 15 years of age and over
  • All patients who give written consent according to guidelines at Asan Medical Center committee on human research

Exclusion Criteria:

  • Patients who refuse to give consent to registering
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761695
Other Study ID Numbers AMC-HEMREG-CML
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dae-Young Kim, Asan Medical Center
Study Sponsor Asan Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Dae-Young Kim, MD Assistant Professor
PRS Account Asan Medical Center
Verification Date July 2018