Chronic Myelod Leukemia Registry at Asan Medical Center

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 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: January 13, 2015

Last verified: January 2015

History of Changes

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:

MedlinePlus related topics: Chronic Myeloid Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Leukemia, Myeloid

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:

Acquisition of informed concent form
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)
Accumulation of data for 30 years
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Dae-Young Kim, MD, PhD	82-2-3010-5930	dani@amc.seoul.kr
Contact: Ji Eun Park, RN	82-2-3010-8261	je3.park@gmail.com

Locations


Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Dae-young Kim, MD, PhD 82-2-3010-5930 dani@amc.seoul.kr
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 13, 2015
Health Authority:	South Korea: Institutional Review Board

Additional relevant MeSH terms:


Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Chronic-Phase	Bone Marrow Diseases Hematologic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on March 03, 2015

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