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

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
Leukemia, Chronic Myeloid; Myeloid Leukemia, Chronic, Accelerated Phase; Myeloid Leukemia, Chronic, Chronic Phase	Other: Diagnosed as CML

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• 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
• Study Start Date: January 2013
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Groups and Cohorts

Group/Cohort	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 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

Outcome Measures

Primary Outcome Measures :

1. Overall survival [ Time Frame: 30 years ]

Secondary Outcome Measures :

1. 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'.
2. 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.

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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of, 138-736

Sponsors and Collaborators

Asan Medical Center

Investigators

• Principal Investigator: Dae-Young Kim, MD; Assistant Professor

More Information

Additional Information:

• Responsible Party: Dae-Young Kim, Assistant Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT01761695
• Other Study ID Numbers: AMC-HEMREG-CML
• First Posted: January 7, 2013
• Last Update Posted: July 20, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

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