Chronic Myelod Leukemia Registry at Asan Medical Center

• ClinicalTrials.gov Identifier: NCT01761695
• Recruitment Status: Terminated
• First Posted: January 7, 2013
• Last Update Posted: July 20, 2018
• Sponsor: Asan Medical Center
• 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

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

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

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