Acute Lymphoblastic Leukemia Registry at Asan Medical Center

July 19, 2018 updated by: Dae-Young Kim, Asan Medical Center

Prospective Observational Cohort Registry for Patients With Acute Lymphoblastic Leukemia at Asan Medical Center

The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 10 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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • All patients who are diagnosed and/or treated as acute lymphoblastic leukemia at Asan Medical Center (including biphenotypic acute leukemia with Philadelphila-positive, Burkitt leukemia/lymphoma)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ph-ALL
Diagnosed as ALL with Philadelphia-negative
Other: Diagnosed as ALL
All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047
Other Names:
  • Diagnosed as acute lymphoblastic leukemia
Ph+ALL
Diagnosed as ALL with Philadelphia-positive (including biphenotypic acute leukemia with Philadelphia-positive)
Other: Diagnosed as ALL
All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047
Other Names:
  • Diagnosed as acute lymphoblastic leukemia
Other ALL
Diagnosed as ALL of other type, including Burkitt leukemia
Other: Diagnosed as ALL
All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047
Other Names:
  • Diagnosed as acute lymphoblastic leukemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 10 year
10 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 10 years
Definition of events will be as 'relapse', 'death from any cause'. Relapse will be defined as hematologic relapse and molecular relapse, respectively when the patient is diagnosed as Philadelphia-positive acute lymphoblastic leukemia
10 years
Relapse-free survival
Time Frame: 10 years
Relapse will be defined as hematologic relapse and molecular relapse, respectively when the patient is diagnosed as Philadelphia-positive acute lymphoblastic leukemia
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Dae-Young Kim, MD, PhD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-HEMREG-ALL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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