Chronic Myelod Leukemia Registry at Asan Medical Center

Leukemia, Chronic Myeloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01761695
• Other study ID #: AMC-HEMREG-CML
• Status: Terminated
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: July 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Leukemia
• Leukemia, Chronic Myeloid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase
• 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		30 years
Secondary	Event-free survival	Definition of events will be as 'failure', 'progress to AP/BC', 'intolerant and medication change', and 'death from any cause'.	30 years
Secondary	Failure-free survival	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.	30 years