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Acute Lymphoblastic Leukemia Registry at Asan Medical Center

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ClinicalTrials.gov Identifier: NCT01761682
Recruitment Status : Terminated (The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.)
First Posted : January 7, 2013
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dae-Young Kim, Asan Medical Center

Study Description
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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
Leukemia, Acute Lymphoblastic Precursor B-Cell Lymphoblastic Leukemia Leukemia, Biphenotypic, Acute Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Lymphoblastic Lymphoma 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)
  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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 10 year ]

Secondary Outcome Measures :
  1. 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

  2. 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


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
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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 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761682


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Dae-Young Kim, MD, PhD Associate Professor
More Information
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Additional Information:

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Responsible Party: Dae-Young Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01761682     History of Changes
Other Study ID Numbers: AMC-HEMREG-ALL
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Biphenotypic, Acute
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases