NCT01653613

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).

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2012

Enrollment Period

2.5 years

First QC Date

July 27, 2012

Last Update Submit

July 9, 2013

Conditions

Leukemia

Keywords

B-cell adult acute lymphoblastic leukemiaB-cell childhood acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (3)

  • Identification of somatically acquired genetic copy number and sequence alterations

  • 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

  • Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion

Interventions

DNA analysisGENETIC
fluorescence in situ hybridizationGENETIC
gene expression analysisGENETIC
microarray analysisGENETIC
mutation analysisGENETIC
polymorphism analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age16 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia

Interventions

In Situ Hybridization, FluorescenceGene Expression ProfilingMicroarray AnalysisAmplified Fragment Length Polymorphism AnalysisReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationMicrochip Analytical ProceduresDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Charles Mullighan, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

August 1, 2010

Primary Completion

February 1, 2013

Last Updated

July 10, 2013

Record last verified: 2012-07