Molecular Genetic Lesions and Clinical Outcomes in Children 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: NCT00003291
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 8, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.

Condition or disease Intervention/treatment
Leukemia Genetic: cytogenetic analysis Genetic: mutation analysis Other: laboratory biomarker analysis

Detailed Description:


  • Examine the prognostic significance of deletion of the p16 (MTS1, CDKN21) gene in children with acute lymphoblastic leukemia.
  • Attempt to correlate the incidence of specific, nonrandom combinations of molecular genetic lesions with clinical outcome in these patients.

OUTLINE: Patients are stratified by risk (standard vs high).

Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Patients are followed for at least 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients
Study Start Date : March 1998
Actual Primary Completion Date : March 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed acute lymphoblastic leukemia (ALL)
  • Meets criteria for 1 of the following:

    • Standard risk, as defined by the following:

      • 1 to 10 years old at diagnosis
      • WBC less than 50,000/mm^3
    • High risk, as defined by the following:

      • Less than 1 year old or over 10 years old at diagnosis
      • WBC greater than 50,000/mm^3
  • Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)



  • See Disease Characteristics

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • 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): NCT00003291

Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Ursula R. Kees, PhD Telethon Institute for Child Health Research

Responsible Party: Children's Oncology Group Identifier: NCT00003291     History of Changes
Other Study ID Numbers: B969
COG-B969 ( Other Identifier: Children's Oncology Group )
CCG-B969 ( Other Identifier: Children's Cancer Group )
CDR0000066224 ( Other Identifier: Clinical )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases