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Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003933
Collaborator
National Cancer Institute (NCI) (NIH)
41
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.

Condition or Disease Intervention/Treatment Phase
  • Other: laboratory biomarker analysis
 N/A

Detailed Description

OBJECTIVES:

  • Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941.

  • Determine the prognostic importance of p16/p15 abnormalities in these children.

  • Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients.

OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15.

PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Diagnostic
Official Title:
The Incidence and Prognostic Significance of P16 INK4A/ P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941
Study Start Date :
Apr 1, 1999
Actual Primary Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Diagnosis of acute lymphocytic leukemia and treated on protocol CCG-1941

    • Material cryopreserved in the CCG cell bank

    PATIENT CHARACTERISTICS:
    Age:
    • Children
    Performance status:
    • Not specified
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:
    • Not specified
    Renal:
    • Not specified
    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • Not specified
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • Not specified
    Surgery:
    • Not specified
    Other:
    • See Disease Characteristics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Long Beach Memorial Medical Center Long Beach California United States 90806
    2 Children's Hospital Los Angeles Los Angeles California United States 90027-0700
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 Children's Hospital of Orange County Orange California United States 92868
    5 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    6 David Grant Medical Center Travis Air Force Base California United States 94535
    7 Children's Hospital of Denver Denver Colorado United States 80218
    8 Children's National Medical Center Washington District of Columbia United States 20010-2970
    9 Shands Hospital and Clinics, University of Florida Gainesville Florida United States 32610-100277
    10 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    11 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    12 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242-1009
    13 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    14 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    15 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    16 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    17 Children's Mercy Hospital Kansas City Missouri United States 64108
    18 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    19 Saint Peter's University Hospital New Brunswick New Jersey United States 08901-1780
    20 Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    21 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    22 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    23 Mount Sinai School of Medicine New York New York United States 10029
    24 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    25 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    26 Veterans Affairs Medical Center - Fargo Fargo North Dakota United States 58102
    27 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    28 Children's Hospital Medical Center - Cincinnati Cincinnati Ohio United States 45229-3039
    29 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    30 Children's Hospital of Columbus Columbus Ohio United States 43205-2696
    31 Doernbecher Children's Hospital Portland Oregon United States 97201-3098
    32 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    33 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    34 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    35 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    36 Children's Hospital and Regional Medical Center - Seattle Seattle Washington United States 98105
    37 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    38 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164
    39 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
    40 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    41 IWK Health Centre Halifax Nova Scotia Canada B3J 3G9

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Stephen P. Hunger, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003933
    Other Study ID Numbers:
    • B9805
    • COG-B9805
    • CCG-B9805
    • CDR0000067125
    First Posted:
    May 2, 2003
    Last Update Posted:
    Aug 7, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Children's Oncology Group
    recurrent childhood acute lymphoblastic leukemia
    Additional relevant MeSH terms:
    Leukemia

    Study Results

    No Results Posted as of Aug 7, 2014