Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia

Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00003291

Enrollment

200

Registered

2003-01-27

Start date

1998-03-31

Completion date

Unknown

Last updated

2014-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia

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.

Detailed description

OBJECTIVES: * 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.

Interventions

GENETICcytogenetic analysis

GENETICmutation analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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) PATIENT CHARACTERISTICS: Age: * See Disease Characteristics Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics 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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026