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Biomarkers in DNA Samples From Patients With High-Risk 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: NCT01119586
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : July 11, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

Condition or disease Intervention/treatment
Leukemia Genetic: DNA analysis Genetic: genetic linkage analysis Genetic: microarray analysis Genetic: nucleic acid sequencing Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis

Detailed Description:


  • To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
  • To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
  • To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
  • To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.

OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing
Study Start Date : February 2013
Actual Primary Completion Date : December 2015

Primary Outcome Measures :
  1. Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis
  2. Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation

Biospecimen Retention:   Samples With DNA

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:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With High-Risk Acute Lymphoblastic Leukemia


  • Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia

    • Matched patients non-tumor and blast DNA samples
    • Enrolled on COG-P9906 or COG-AALL0232 protocols
  • Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri


  • Newborn infants from the state of Missouri


  • 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): NCT01119586

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Todd E. Druley, MD St. Louis Children's Hospital
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Responsible Party: Children's Oncology Group Identifier: NCT01119586    
Other Study ID Numbers: AALL10B2
COG-AALL10B2 ( Other Identifier: Children's Oncology Group )
CDR0000672526 ( Other Identifier: )
NCI-2011-02232 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by Children's Oncology Group:
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