Clincosm LogoSign in Get a demo

Acute Lymphoblastic Leukemia Registry at Asan Medical Center

Sponsor
Asan Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01761682
Collaborator
(none)
200
Enrollment
1
Location
40
Duration (Months)
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 acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

Condition or Disease Intervention/Treatment Phase
  • Other: Diagnosed as ALL

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)

  1. Accumulation of data for 30 years

  2. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Observational Cohort Registry for Patients With Acute Lymphoblastic 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
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [10 year]

    Secondary Outcome Measures

    1. Event-free survival [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

    2. Relapse-free survival [10 years]

      Relapse will be defined as hematologic relapse and molecular relapse, respectively when the patient is diagnosed as Philadelphia-positive acute lymphoblastic leukemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dae-Young Kim, Assistant Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT01761682
    Other Study ID Numbers:
    • AMC-HEMREG-ALL
    First Posted:
    Jan 7, 2013
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Biphenotypic, Acute

    Study Results

    No Results Posted as of Jul 20, 2018