Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

NCT ID: NCT01653613

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31

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).

Detailed Description

OBJECTIVES:

• 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).

Conditions

Leukemia

Interventions

DNA analysis

Intervention Type: GENETIC

fluorescence in situ hybridization

Intervention Type: GENETIC

gene expression analysis

Intervention Type: GENETIC

microarray analysis

Intervention Type: GENETIC

mutation analysis

Intervention Type: GENETIC

polymorphism analysis

Intervention Type: GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

ECOG Group Chair's Office

Principal Investigators

Charles Mullighan, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Other Identifiers

CDR0000737435

Identifier Type: REGISTRY

Identifier Source: secondary_id

ECOG-E2L10T1

Identifier Type: -

Identifier Source: org_study_id