Chronic Myelod Leukemia Registry at Asan Medical Center

Sponsor

Asan Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01761695

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Chronic Myeloid Myeloid Leukemia, Chronic, Accelerated Phase Myeloid Leukemia, Chronic, Chronic Phase	Other: Diagnosed as CML

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)

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Cohort Registry for Patients With Chronic Myeloid Leukemia at Asan Medical Center

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: Diagnosed as chronic myeloid leukemia

Outcome Measures

Primary Outcome Measures

Overall survival [30 years]

Secondary Outcome Measures

Event-free survival [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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