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CML Registry at AMC

This study is currently recruiting participants.
Verified January 2013 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Dae-Young Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01761695
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Leukemia, Chronic Myeloid
Myeloid Leukemia, Chronic, Accelerated Phase
Myeloid Leukemia, Chronic, Chronic Phase
 Other: Diagnosed as CML

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Prospective Observational Cohort Registry for Patients With Chronic Myeloid Leukemia at Asan Medical Center

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 30 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Time Frame: 30 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 1050
Study Start Date: January 2013
Estimated Study Completion Date: December 2047
Estimated Primary Completion Date: December 2047 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CML CP
Diagnosed as CML with chronic phase
 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
CML AP
Diagnosed as CML with accelerated phase
 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
CML BC
Diagnosed as CML with blast crisis
 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
CML other
Diagnosed as CML, which is not included in any of other category
 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

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)
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are diagnosed and/or treated with chronic myeloid leukemia at Asan Medical Center, Seoul, Korea

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761695

Contacts
Contact: Park, RN 82-2-3010-7290 peechss@naver.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Park, RN     82-2-3010-7290     peechss@naver.com    
Sub-Investigator: Kyoo-Hyung Lee, MD, PhD            
Principal Investigator: Dae-Young Kim, MD            
Sub-Investigator: Je-Hwan Lee, MD, PhD            
Sub-Investigator: Jung-Hee Lee, MD, PhD            
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Dae-Young Kim, MD Assistant Professor
  More Information

No publications provided

Responsible Party: Dae-Young Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01761695     History of Changes
Other Study ID Numbers: AMC-HEMREG-CML
Study First Received: January 3, 2013
Last Updated: January 3, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Chronic Disease
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013