search
Back to results

Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

Primary Purpose

Leukemia

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
DNA analysis
fluorescence in situ hybridization
gene expression analysis
microarray analysis
mutation analysis
polymorphism analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Leukemia focused on measuring B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia

Eligibility Criteria

16 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Samples from patients diagnosed with B-progenitor AYA ALL from:

    • The Children's Oncology Group high risk ALL Study AALL0232 (age 16-21)
    • The St. Jude Children's Research Hospital (SJCRH) Total XV studies (age 16-21)
    • AYA ALL (from patients 22-30 years of age and from patients age 31-39 years) existing in the ALL Tissue Repositories of the adult National Cancer Institute (NCI) Cooperative Oncology Groups

      • The Cancer and Leukemia Group B (CALGB)
      • The Eastern Cooperative Oncology Group (ECOG)
      • The Southwest Oncology Group (SWOG)
  • Cryopreserved viable leukemic cell suspensions, obtained from bone marrow or peripheral blood at pretreatment and initial diagnosis
  • Matched normal (germline) samples from end induction-remission bone marrow or blood samples or from buccal swabs, if available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Identification of somatically acquired genetic copy number and sequence alterations
    Associations between genetic lesions (including mutations and copy number alterations) and known prognostic factors such as age group and white blood count at the time of diagnosis group using a Fisher exact test or Chi squared
    Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2012
    Last Updated
    July 9, 2013
    Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01653613
    Brief Title
    Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
    Official Title
    Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    February 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eastern Cooperative Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This laboratory study is looking into genes in samples from younger patients with acute lymphoblastic leukemia (ALL).
    Detailed Description
    OBJECTIVES: To identify somatically acquired genetic copy number and sequence alterations at the time of diagnosis in adolescent and young adults (AYA) acute lymphoblastic leukemia (ALL) samples and to correlate them with clinical and laboratory characteristics and outcome. To identify specific microarray multi-gene and multi-exon expression signatures at the time of diagnosis and to correlate them with clinical and laboratory characteristics and outcome. To gain insights into the genetic events that contribute to the formation, development and relapse of AYA ALL by integrating the copy number and sequence alterations with the multi-gene signatures and by comparing these with data already generated in pediatric ALL. OUTLINE: Cryopreserved samples are analyzed for DNA copy number alterations and loss-of-heterozygosity, gene expression profiling, and mutation analysis by single nucleotide polymorphism (SNP) microarrays, Affymetrix Exon arrays, and whole genome amplification (WGA, Repli-G Qiagen). Confirmation studies are then done by fluorescence in situ hybridization (FISH), reverse transcriptase (RT)-polymerase chain reaction (PCR), and rapid amplification of cDNA ends (RACE).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia
    Keywords
    B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia

    7. Study Design

    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    DNA analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    fluorescence in situ hybridization
    Intervention Type
    Genetic
    Intervention Name(s)
    gene expression analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    microarray analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    mutation analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    polymorphism analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    reverse transcriptase-polymerase chain reaction
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Identification of somatically acquired genetic copy number and sequence alterations
    Title
    Associations between genetic lesions (including mutations and copy number alterations) and known prognostic factors such as age group and white blood count at the time of diagnosis group using a Fisher exact test or Chi squared
    Title
    Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Samples from patients diagnosed with B-progenitor AYA ALL from: The Children's Oncology Group high risk ALL Study AALL0232 (age 16-21) The St. Jude Children's Research Hospital (SJCRH) Total XV studies (age 16-21) AYA ALL (from patients 22-30 years of age and from patients age 31-39 years) existing in the ALL Tissue Repositories of the adult National Cancer Institute (NCI) Cooperative Oncology Groups The Cancer and Leukemia Group B (CALGB) The Eastern Cooperative Oncology Group (ECOG) The Southwest Oncology Group (SWOG) Cryopreserved viable leukemic cell suspensions, obtained from bone marrow or peripheral blood at pretreatment and initial diagnosis Matched normal (germline) samples from end induction-remission bone marrow or blood samples or from buccal swabs, if available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Mullighan, MD
    Organizational Affiliation
    St. Jude Children's Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

    We'll reach out to this number within 24 hrs