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Cohort for biomarkers to predict prognosis and treatment response in acute leukemia

Status Approved

  • First Submitted Date

    2017/02/01

  • Registered Date

    2017/03/10

  • Last Updated Date

    2020/08/10

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002261
    Unique Protocol ID KC16TISI0438
    Public/Brief Title Cohort for biomarkers to predict prognosis and treatment response in acute leukemia
    Scientific Title Cohort for biomarkers to predict prognosis and treatment response in acute leukemia
    Acronym Pre-cohort AML
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KC16TISI0438
    Approval Date 2016-07-08
    Institutional Review Board Name The Catholic University of Korea, Seoul St. Mary's Hospital Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hee-Je Kim
    Title Professor
    Telephone +82-2-2258-6039
    Affiliation The Catholic University of Korea
    Address 222 Banpo-daero, seocho-gu, seoul
    Contact Person for Public Queries
    Name Young-woo Jeon
    Title Clinical associate p
    Telephone +82-2-2258-6038
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address 222 Banpo-daero, seocho-gu, seoul
    Contact Person for Updating Information
    Name Young-woo Jeon
    Title Clinical associate p
    Telephone +82-2-2258-6038
    Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital
    Address 222 Banpo-daero, seocho-gu, seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2016-07-08 Actual
    Target Number of Participant 1500
    Primary Completion Date 2025-12-31 , Anticipated
    Study Completion Date 2025-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-07-08 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
    Project ID KC16TISI0438
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Seoul St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Under the treatment of acute leukaemia, which is based on the classification of acute leukaemia in the treatment of acute leukemia, adapted is now considered a major treatment strategy. In order to achieve these things, chromosome and molecular cell abnormalities are essential, and the need for further reporting and validation of other additional biomakers is necessary, considering that acute leukaemia has a highly diverse pathophysiological mechanisms. In addition, for the implantation of hematopoietic stem cell transplants, the need for transplant transplants and associated biological markers to monitor post-transplant immunologic remodeling is necessary to minimize the risk of transplant complications and reduce the transplantaion-related death. Thus, at time points of initial diagnosis and adaptation of each therapeutic modalities, prospective clinical data and samples will help for analysing of probable cell, proteins, chromsome (DNA, RNA, miRNA, etc) as prognostic biomarkers. 
    The objective of this study is to establish a cohort for discovering the prognosis for acute leukaemia patients for acute leukaemia patients and stratification, which will be explored by research and development.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Others  
    Target Number of Participant 1500
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Patient group

    Cohort/Group Description

    A group of patients who have been received a allogeneic hematopoietic stem cell transplantation for AML: the acquisition of  Bone marrow aspirate and serum blood at diagnosis and follow-up period
    Cohort/
    Group 2

    Cohort/Group Label

    Heathy donor group

    Cohort/Group Description

    a group of healthy donor have been given a donation of bone marrow cells: the acquisition of  Bone marrow aspirate and serum blood at once
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample with DNA
    Biospecimen Description
    1) patient group: serum, blood cell. bone marrow aspirate, epithelial cells by buccal swap ( or hair )  2) healthy donor group: serum, blood cells, bone marrow aspirate
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    1) patient group: patients with suspected acute leukemia or confirmation of aacute leukemia.
    2) healthy donor group: healthy donor who donated with bone marrow cells
    Sampling Method
    Because this study is to establish the cohort about patients newly diagnosed with AML prospectively and analysis the retrospective data by using the electronic medical record, It does not calculate the sample size on the basis of statistical power. In step 2, based on our center’s historical data ( 170~250 patients/year), all about 1,500 patients who fit with inclusion criteria will register and analysis for 5 years.
    Condition(s)/Problem(s)    (D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    1) patient group
      ① step 1: adult with over 18-year-old, patients who confirmed of acute leukemia by WHO classification, patients who can be checked the electronic medical record
     ② step 2: adult with over 18-year-old, patients who suspected of acute leukemiaL, and then confirmed with bone marrow apsirate by WHO classification,  Patients with voluntary informed consent about blood and bone marrow sampling.
    
    2) healthy donor group
     : among the all hematopoietic stem cell donors, healthy donor who donated with bone marrow cells 
    Exclusion Criteria
    patients who not finally confirmed of acute leukemia by WHO classification
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Characteristics of patient and leukemia at diagnosis, type of chemotherapy, chemotherapy response, hematopoietic stem cell transplantation and related-survival rate, incidence of HSCT-related complications
    Timepoint
    Batch analysis after completion of study
    Secondary Outcome(s) 1
    Outcome
    Promising biomarker determination
    Timepoint
    Batch analysis after completion of study
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration

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