Acute Lymphoblastic Leukemia Registry at Asan Medical Center

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Dae-Young Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01761682
First received: January 3, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Leukemia, Acute Lymphoblastic
Precursor B-Cell Lymphoblastic Leukemia
Leukemia, Biphenotypic, Acute
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Lymphoblastic Lymphoma
Other: Diagnosed as ALL

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Observational Cohort Registry for Patients With Acute Lymphoblastic Leukemia at Asan Medical Center

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 10 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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

  • Relapse-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Relapse will be defined as hematologic relapse and molecular relapse, respectively when the patient is diagnosed as Philadelphia-positive acute lymphoblastic leukemia


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: 1400
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
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 Name: 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 Name: 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 Name: Diagnosed as acute lymphoblastic leukemia

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)
  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 acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea

Criteria

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
  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: NCT01761682

Contacts
Contact: Ji-Young Min, RN 82-2-3010-7290 miracleminjy@naver.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Park, RN    82-2-3010-7290    peechss@naver.com   
Principal Investigator: Dae-Young Kim, MD         
Sub-Investigator: Kyoo-Hyung Lee, MD, PhD         
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: NCT01761682     History of Changes
Other Study ID Numbers: AMC-HEMREG-ALL
Study First Received: January 3, 2013
Last Updated: July 8, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Lymphoma, Non-Hodgkin
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Biphenotypic, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma

ClinicalTrials.gov processed this record on September 18, 2014