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Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653613
Recruitment Status : Unknown
Verified July 2012 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2012
Last Update Posted : July 10, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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).

Condition or disease Intervention/treatment
Leukemia Genetic: DNA analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymorphism analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

Detailed Description:


  • 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).

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Study Type : Observational
Estimated Enrollment : 400 participants
Official Title: Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia
Study Start Date : August 2010
Estimated Primary Completion Date : February 2013

Primary Outcome Measures :
  1. Identification of somatically acquired genetic copy number and sequence alterations
  2. 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
  3. Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • Not specified

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 identifier (NCT number): NCT01653613

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Charles Mullighan, MD St. Jude Children's Research Hospital
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Responsible Party: Robert L. Comis, ECOG Group Chair's Office Identifier: NCT01653613    
Other Study ID Numbers: ECOG-E2L10T1
CDR0000737435 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2012
Keywords provided by National Cancer Institute (NCI):
B-cell adult acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases